OpenLegislation

Division 3 Transformation event component

United Kingdom

Original text. Later amendments are not shown.

The second set of five or six alphanumerical digits should represent the specific transformation event(s), which is the subject of the application for the placing on the market and/or consent, such as:

or

Clearly, an individual transformation event may occur in different organisms, species and varieties and the digits should be representative of the specific event in question. Again, applicants should, prior to formulating unique identifiers, consult the OECD BioTrack product database in terms of the unique identifiers that have been assigned to similar transformation events of the same organism/species in order to provide consistency and to avoid duplication.

Applicants should develop their own internal mechanism to avoid applying the same designation (digits) to a "transformation event" if used in a different organism. Where similar transformation events are developed by two or more organisations, the "applicant information" (see section 2) should enable applicants to generate a unique identifier for their own product, while at the same time ensuring its uniqueness from those generated by other applicants.

As regards new GMOs compromising more than one transformation event (often referred to as stacked-gene transformation events), applicants or consent holders should generate a novel unique identifier for such GMOs.

Notes on Annex

Textual amendments

F1

Words in Annex Section A para. 1 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(7)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in Annex Section B substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/90), regs. 1(2)(b), 6(7)(b) (as amended by S.I. 2020/1421, reg. 1(4), Sch. para. 4(3)); 2020 c. 1, Sch. 5 para. 1(1)