Same Molecule, Different Ingredient? Why Manufacturing Route Is Becoming Part of Regulatory Identity

A recent EFSA opinion on rebaudioside M exposes a regulatory principle with consequences far beyond sweeteners: in modern food biotechnology, chemical identity alone may no longer define the regulatory identity of an ingredient. On 17 September 2026, EFSA concluded that rebaudioside M produced through a new enzymatic bioconversion process using enzymes from genetically modified Escherichia coli K-12 DSM 35119 raises no safety concern. Yet the Panel recommended creating a new legislative entry rather than simply amending existing E 960c specifications, because the production microorganism, starting material, purification route and minor-glycoside profile differed. This creates an instructive paradox: the principal molecule can be physicochemically equivalent and toxicologically covered by existing evidence, while the product remains sufficiently process-distinct to require separate regulatory definition. This article argues that food regulation is moving toward process-defined identity for biotechnology-derived ingredients. It examines the scientific, legal and commercial implications for precision fermentation, enzyme-assisted bioconversion, functional ingredients and international market access, and proposes a practical framework for regulatory comparability by design.