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

• Citation: S.I. 1996/1106
• Sections: 3

Section 1 Citation, commencement, revocation and interpretation

(1) These Regulations may be cited as the Genetically Modified Organisms (Risk Assessment)(Records and Exemptions) Regulations 1996 and shall come into force on 9th May 1996.

(2) The Genetically Modified Organisms (Contained Use) Regulations 1993 are hereby revoked.

(3) In these Regulations—

“ the Act ” means the Environmental Protection Act 1990, and

“the Contained Use Regulations ” means the Genetically Modified Organisms (Contained Use) Regulations 2014 .

Section 2 Duty to keep records of risk assessments

The period for which a person who carries out an assessment under section 108(1)(a) of the Act (Risk assessment and notification requirements) shall keep a record of that assessment shall be ten years.

Section 3 Exemptions from requirement to carry out risk assessments

(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 2 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(1) of, and Part III of Schedule 2 to the Contained Use Regulations, those Regulations do not apply;

(c) are or are contained in a medicinal product which is authorised for marketing under the Human Medicines Regulations 2012 or the Veterinary Medicines Regulations 2013 ;

(d) consist of, or are included in, a product which has marketing consent immediately before exit day under Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms or Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms —

(i) which is imported or acquired in accordance with the conditions and limitations on the use of the product specified in the consent, and

(ii) in the case of a consent for genetically modified carnations ( Dianthus caryophyllus ), where the product is imported or acquired within 10 years of the date on which the consent was issued;

(e) consist of, or are included in, a product which is authorised for marketing under—

(i) in relation to England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

(ii) in relation to Wales, the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

(iii) in relation to Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;

(f) are genetically modified organisms which are approved for food or feed use in the United Kingdom.