This Opinion is the first of a set of three Opinions addressing a mandate on Synthetic Biology (SynBio) from DG SANCO, DG RTD, DG Enterprise and DG Environment requested to the three Scientific Committees (SCs). This first Opinion concentrates on the elements of an operational definition for SynBio. The two Opinions that follow focus on the methodology to determine what, if any, risks SynBio may potentially pose to public health and what type of further research in this field is required.This first Opinion lays the foundation for the two other Opinions with an overview of the main scientific concepts, developments, tools and research areas in SynBio. Additionally, a summary of relevant regulatory aspects in the European Union (EU), in other countries such as the USA, Canada, South America, China, and at the United Nations is included.Current definitions of SynBio generally emphasise modularisation and engineering concepts as the main drivers for faster and easier GMO design, manufacture and exploitation. However, the operational definition offered by the Scientific Committees here addresses the need for a definition that enables risk assessment and is sufficiently broad to include new developments in the field. Therefore, for the purpose of these Opinions, this is the operational definition derived from a working understanding of SynBio as a collection of conceptual and technological advances:SynBio is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms.It is difficult to accurately define the relationship between genetic modification and SynBio on the basis of quantifiable and currently measurable inclusion and exclusion criteria. Thus, in addition to the definition, a list of specific criteria was considered reflecting that SynBio covers any organism, system, material, product, or application resulting from introduction, assembly, or alteration of the genetic material in a living organism. Although these criteria are helpful guiding principles that specify whether or not a certain process, tool or product belongs to SynBio, none are quantifiable or measurable. Additional criteria including the complexity of the genetic modification, the speed by which modification was achieved, the number of independent modifications, or the degree of computational design methods used, alone or in combination, are also unable to unambiguously differentiate SynBio processes or products from GM.This definition has the advantage that it does not exclude the relevant and large body of risk assessment and safety guidelines developed over the past 40 years for GM work and extensions of that work, if needed, to account for recent technological advances in SynBio. Additionally, the present definition also enables the rapidly advancing nature of GM technologies and adds an important nuance that supports the need for on-going updates of risk assessment methods, which will be addressed in Opinion II.
