Laboratory strains and the EU ABS Regulation

Published on
February 8, 2022

Laboratory strains are key resources for research. Viruses, microbes, plants and animals are modified by laboratories to create laboratory strains that meet specific scientific needs. Are the creation and utilisation of laboratory strains in scope of the EU ABS Regulation?

A laboratory strain is a strain of living organisms or viruses that has particular properties that make it unique and is available for mass production and transfer to third parties. The strains generally have low or no genetic heterozygosity for traits of interest, are often inbred or clonal and are characterised by a genetic and/or biochemical composition that has been intentionally created or conserved. In addition, laboratory strains can be managed under a record of laboratory maintenance over several generations, with a publicly traceable history regarding ancestry and/or pedigree.

Laboratory strains of rats and mice, for example, are commonly used for disease modeling in biomedical studies, with thousands of different strains being available for a range of diseases and traits. Laboratory strains have also been developed in microbial species (e.g. Escherichia coli strains), plant species (e.g. Arabidopsis plants) and viruses (e.g. of the Herpes simplex virus).

Creating a new laboratory strain

New strains can be created from genetic material by intentional genetic modification or by selecting and conserving mutations that occurred uninentionally during sub-culturing, prolonged storage or as a result of preservation technologies.

The creation of a new strain (which may over time become a new laboratory strain) based on material in scope of the EU ABS Regulation is itself in scope of the EU ABS Regulation, as utilisation (research and development on the genetic and/or biochemical composition) of genetic resources takes place to create the new strain.

A newly created strain based on material in scope of the EU ABS Regulation remains in scope of the EU ABS Regulation as long as it is not publicly available to others for research and development purposes. Before the strain is made publicly available to others, the developer of the laboratory strain needs to submit a due diligence declaration.

Utilisation of a laboratory strain

After a strain has become a laboratory strain and is made publicly available to others, its further use is out of scope of the EU ABS Regulation. However, contractual agreements agreed in PIC and MAT concerning benefit-sharing resulting from further use of newly developed laboratory strains need to be respected.

For more information on laboratory strains, see section 7.5 of Annex II of the EU Guidance

Laboratory strains as testing and reference tools

When a genetic resource is used as a testing or reference tool, the material is not the object of the research in itself, but only serves to confirm or verify the desired features of other products developed or under development. This means that using laboratory strains as testing and reference tools is not considered to be utilisation in the meaning of the EU ABS Regulation. Examples are the use of laboratory animals to test their reaction to medical products, pathogens for testing the resistance of plant varieties, or bacteria for testing the effectiveness of compounds that are candidates for new antibiotics.

For more information about testing and reference tools, read the article ‘Utilisation: taxonomic identification and testing and reference tools’.