The Genetically Modified Organisms (Contained Use) Regulations 2014

Regulations 2(1) and 3(1)

SCHEDULE 2

PART 1 Techniques constituting genetic modification

1.  The techniques which constitute genetic modification referred to in sub-paragraph (a) of the definition of “genetic modification” in regulation 2(1) are—

(a) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

(b) techniques involving the direct introduction into an organism of heritable genetic material prepared outside the organism, including micro-injection, macro-injection and micro-encapsulation;

(c) cell fusion or hybridization techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

PART 2 Techniques which are not considered to result in genetic modification

2.  The following techniques are not considered to result in genetic modification provided that they do not involve the use of recombinant nucleic acid molecules or of genetically modified organisms made by techniques other than those listed in Part 3—

(a) in vitro fertilisation;

(b) natural processes including conjugation, transduction or transformation;

(c) polyploidy induction.

PART 3 Techniques to which these Regulations do not apply

3.  These Regulations (except regulation 18) do not apply to the following techniques of genetic modification, provided that they do not involve the use of recombinant nucleic acid molecules or of genetically modified organisms other than those made by one or more of the following techniques—

(a) mutagenesis;

(b) cell fusion (including protoplast fusion) of prokaryotic species which can exchange genetic material through homologous recombination;

(c) cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions;

(d) self-cloning, where the resulting organism is unlikely to cause disease or harm to humans, animals or plants.

4.  In paragraph 3—

(a) “self-cloning” means the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), whether or not altered by enzymic or mechanical processes, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by homologous recombination; and

(b) self-cloning may include the use of recombinant vectors, with an extended history of safe use in the particular organism, to manipulate and reinsert the nucleic acid sequences, but the vectors must not consist of any genetic elements other than those designed for vector structure, vector replication, vector maintenance or marker genes.