European Commission ABS Sectoral Guidance: Key Issues for Business
Based on the views of most key sectors, ICC has prepared the current paper to help increase the clarity needed on the issue of derivatives by both users and Member States Competent Authorities.
A difficulty faced by users when seeking to understand the nature and scope of their obligations under the EU ABS Regulation relates to so-called derivatives.
Whereas no direct reference is made to obligations applying to such materials in the EU ABS Regulation, the Horizontal Guidance of the European Commission provides that access to a derivative is covered when it also includes genetic resources for utilisation. Those limited provisions, while welcomed, do not give the clarity needed by users to ascertain when, and to what extent, activities conducted on derivatives trigger compliance obligations under the EU ABS Regulation.
ICC proposes in the present paper to build upon the Commission’s interpretation of “combined access” developed in its Horizontal Guidance by endorsing the concept of an ascertainable level of continuity between R&D activities conducted on a derivative and the genetic resource from which it was generated.