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

Explanatory Note

(This note is not part of the Regulations)

These Regulations make provision in relation to section 108(1)(a) of the Environmental Protection Act 1990 (“the Act”), which restricts the import and acquisition of genetically modified organisms (“GMOs”).

They revoke and replace, with certain drafting changes, the Genetically Modified Organisms (Contained Use) Regulations 1993 (S.I. 1993/15) and take account of amendments made to Genetically Modified Organisms (Contained Use) Regulations 1992 (S.I. 1992/3217) (“the Contained Use Regulations 1992”) by the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 1996 (S.I. 1996/967).

Regulation 2 prescribes the period for which records must be kept of risk assessments required to be carried out under section 108(1)(a) of the Act before importing or acquiring GMOs.

Regulation 3 provides for exemptions from the requirement to carry out risk assessments under section 108(1)(a) of the Act. Where a person imports or acquires GMOs, section 108(1)(a) will not apply in relation to micro-organisms within the meaning of the Contained Use Regulations 1992 or to organisms, other than micro-organisms, modified by application of the techniques set out in Parts II and III of Schedule 1 to the Contained Use Regulations 1992.

Regulation 3 provides for an exemption where a person imports or acquires GMOs which are or are contained in a medicinal product which is the subject of a market authorisation under Council Regulation (EEC) No. 2309/93 (OJ No. L241 24.8.93). It is also provided that section 108(1)(a) of the Act will not apply to approved products, as defined in the Genetically Modified Organisms (Deliberate Release) Regulations 1992 (S.I. 1992/3280), which are imported or acquired in accordance with the conditions and limitations to which the use of the product is subject.