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

Explanatory Note

(This note is not part of the regulations.)

These Regulations make provision in relation to Article 5(1)(a) of the Genetically Modified Organisms (Northern Ireland) Order 1991 (“the Order”) which restricts the import and acquisition, release and marketing of genetically modified organisms (“GMOs”).

They revoke and replace, with certain drafting changes, the Genetically Modified Organisms (Contained Use) (No. 2) Regulations (Northern Ireland) 1994 (S.R. 1994 No. 145) and take account of amendments made to the Genetically Modified Organisms (Contained Use) Regulations 1994 (S.R. 1994 No. 143) (“the 1994 Contained Use Regulations”) by the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 1996 (S.R. 1996 No. 250).

Regulation 3 prescribes the period for which records must be kept of risk assessments required to be carried out under Article 5(1)(a) of the Order before importing or acquiring GMOs.

Regulation 4 exempts persons who import or acquire GMOs from the requirements of Article 5(1)(a) of the Order where the GMOs to be imported or acquired:—

(a) are genetically modified micro-organisms;

(b) are organisms, other than micro-organisms, 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; 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;

(d) consist of, or are included in, an approved product as defined in the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 1994 which is imported or acquired in accordance with the conditions and limitations to which the use of the product is subject.