Earlier this year, the European Commission published a revised Guidance document on the EU ABS Regulation (Regulation (EU) 511/2014). The revised Guidance document provides more information on the scope and user obligations of the Regulation. In this article we highlight two topics regarding the scope: characterisation and phylogenetic analysis.
In the ABS Focal Point newsletter of February 2021, we explained that taxonomic identification of genetic resources, by morphological or molecular analysis (including through use of DNA sequencing) is not considered to constitute utilisation in the meaning of the EU ABS Regulation, as it does not involve the discovery of specific genetic and/or biochemical properties. Taxonomic studies, where they do not look into genetic properties (functionality), are thus not within scope of the EU ABS Regulation. In this article we highlight two topics closely related to taxonomic identification: characterisation and phylogenetic analysis.
Characterisation is the description and documentation of the distinctive nature or features of genetic resources, which may include gene expression. If these activities do not involve the discovery of specific genetic and/or biochemical functions, it does not ‘create new insight into characteristics of the genetic resource which is of (potential) benefit to the further process of product development’ and therefore does not qualify as utilisation in the meaning of the EU ABS Regulation. For example, when a researcher examines morphological characteristics alone without examining or making use of the genetic influences on the morphology, this does not qualify as utilisation.
However, if the activity does include research on specific genetic and/or biochemical properties of the genetic resources, the activity qualifies as utilisation. This is the case, for example, when research seeks the genetic background of traits of interest, to analyse which genes, gene complexes or regulatory sequences and mechanisms governing their expression are involved.
For more information and case examples, see section 6.2 of the Guidance’s Annex II.
Phylogenetic analysis is a type of data analysis which visualises relationships between samples, usually in the form of branching diagrams (‘trees’) or networks. It can be performed on all kinds of data, including gene functionality data. Research involving phylogenetic analysis using genetic resources may be aimed at identifying variation in identity of the species within and between populations and be similar to taxonomic identification. It may also be aimed at identifying such variation between species or taxa above species such as genus, tribe or family.
Where phylogenetic analysis does not entail research and development into the genes, and the function of the genes or DNA sequences is neither investigated nor of interest, it is considered to be out of scope of the EU ABS Regulation. However, if phylogenetic analysis includes research on the function of the genes, it falls within the scope of the EU ABS Regulation.
For more information and case examples, see section 6.3 of the Guidance’s Annex II.
Want to know more about identification and characterisation in the context of the EU ABS Regulation? Read: ‘Utilisation: taxonomic identification and testing and reference tools’.