Part VIU.K. Genetically Modified Organisms

Extent Information

Modifications etc. (not altering text)

C1Pt. VI (ss. 106-127): transfer of functions (16.2.2000) by S.I. 2000/253, art. 2, Sch. 1

PreliminaryU.K.

106 Purpose of Part VI and meaning of “genetically modified organisms” and related expressions.E+W

[F1(1)This Part has effect for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the escape or release from human control of genetically modified organisms.]

(2)In this Part the term “organism” means any acellular, unicellular or multicellular entity (in any form), other than humans or human embryos; and, unless the context otherwise requires, the term also includes any article or substance consisting of or including biological matter.

(3)For the purpose of subsection (2) above “biological matter” means anything (other than an entity mentioned in that subsection) which consists of or includes—

(a)tissue or cells (including gametes or propagules) or subcellular entities, of any kind, capable of replication or of transferring genetic material, or

(b)genes or other genetic material, in any form, which are so capable,

and it is immaterial, in determining if something is or is not an organism or biological matter, whether it is the product of natural or artificial processes of reproduction and, in the case of biological matter, whether it has ever been part of a whole organism.

(4)For the purposes of this Part an organism is “genetically modified” if any of the genes or other genetic material in the organism—

[F2(a)have been artificially modified, or]

(b)are inherited or otherwise derived, through any number of replications, from genes or other genetic material (from any source) which were so modified.

[F3(4A)Genes or other genetic material in an organism are “artificially modified” for the purposes of subsection (4) above if they are altered otherwise than by a process which occurs naturally in mating or natural recombination.

This subsection is subject to subsections (4B) and (4C) below.

(4B)For the purposes of subsection (4) above—

(a)genes or other genetic material shall be taken to be artificially modified if they are altered using such techniques as may be prescribed for the purposes of this paragraph;

(b)genes or other genetic material shall not be regarded as artificially modified by reason only of being altered by the use of such techniques as may be prescribed for the purposes of this paragraph.

(4C)An organism shall be taken not to be a genetically modified organism for the purposes of this Part if it is an organism of a prescribed description.

(4D)In subsections (4B) and (4C) above “prescribed” means prescribed by regulations made by the Secretary of State.]

(5)[F4The techniques which may be prescribed for the purposes of subsection (4) above include—

(a)any technique for the modification of any genes or other genetic material by the recombination, insertion or deletion of, or of any component parts of, that material from its previously occurring state, and

(b)any other technique for modifying genes or other genetic material which in the opinion of the Secretary of State would produce organisms which should for the purposes of this Part be treated as having been genetically modified,

but do not include techniques which involve no more than, or no more than the assistance of, naturally occurring processes of reproduction (including selective breeding techniques or in vitro fertilisation).]

(6)[F4It is immaterial for the purposes of subsections (4) and (5) above whether the modifications of genes or other genetic material effected by a prescribed technique are produced by direct operations on that genetic material or are induced by indirect means (including in particular the use of viruses, microbial plasmids or other vector systems or of mutation inducing agents).]

(7)In this Part, where the context permits, a reference to “reproduction”, in relation to an organism, includes a reference to its replication or its transferring genetic material.

Extent Information

E2This version of this provision extends to England and Wales only; a separate version has been created for Scotland only

Textual Amendments

Modifications etc. (not altering text)

Commencement Information

I1S. 106 wholly in force at 1.2.1993; s. 106 not in force at Royal Assent see s. 164(2)(3); s. 106(4)(5) in force 1.4.1991 see S.I. 1991/1042, art. 2; s. 106(1)-(3)(6)(7) in force at 1.2.1993 see S.I. 1992/3253, art. 3.

106 Purpose of Part VI and meaning of “genetically modified organisms” and related expressions.S

[F5(1)This Part has effect for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the escape or release from human control of genetically modified organisms.]

(2)In this Part the term “organism” means any acellular, unicellular or multicellular entity (in any form), other than humans or human embryos; and, unless the context otherwise requires, the term also includes any article or substance consisting of or including biological matter.

(3)For the purpose of subsection (2) above “biological matter” means anything (other than an entity mentioned in that subsection) which consists of or includes—

(a)tissue or cells (including gametes or propagules) or subcellular entities, of any kind, capable of replication or of transferring genetic material, or

(b)genes or other genetic material, in any form, which are so capable,

and it is immaterial, in determining if something is or is not an organism or biological matter, whether it is the product of natural or artificial processes of reproduction and, in the case of biological matter, whether it has ever been part of a whole organism.

(4)For the purposes of this Part [F6, subject to subsection (4C) below,] an organism is “genetically modified” if any of the genes or other genetic material in the organism—

[F7(a)have been artificially modified, or]

(b)are inherited or otherwise derived, through any number of replications, from genes or other genetic material (from any source) which were so modified.

[F8(4A)subject to subsections (4B) and (4C) below, genes or other genetic material in an organism are “artificially modified” for the purposes of subsection (4) above if they are altered otherwise than by a process which occurs naturally in mating or natural recombination.

(4B)For the purposes of subsection (4) above–

(a)genes or other genetic material shall be taken to be artificially modified if they are altered using such techniques as may be prescribed for the purposes of this paragraph;

(b)genes or other genetic material shall not be regarded as artificially modified by reason only of being altered by the use of such techniques as may be prescribed for the purposes of this paragraph.

(4C)An organism shall be taken not to be a genetically modified organism for the purposes of this Part if it is an organism of a prescribed description.

(4D)In subsections (4B) and (4C) above, “prescribed” means prescribed by regulations made by the Scottish Ministers.]

(5)F9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6)F9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7)In this Part, where the context permits, a reference to “reproduction”, in relation to an organism, includes a reference to its replication or its transferring genetic material.

Extent Information

E3This version of this provision extends to Scotland only; a separate version has been created for England and Wales only

Textual Amendments

Modifications etc. (not altering text)

Commencement Information

I1S. 106 wholly in force at 1.2.1993; s. 106 not in force at Royal Assent see s. 164(2)(3); s. 106(4)(5) in force 1.4.1991 see S.I. 1991/1042, art. 2; s. 106(1)-(3)(6)(7) in force at 1.2.1993 see S.I. 1992/3253, art. 3.