FROM GRAS TO CONTINUOUS EVIDENCE - Is Food-Ingredient Regulation Entering a New Era of Regulatory Life-Cycle Management?

Food-ingredient regulation is undergoing a structural transition. For decades, the central regulatory question was whether a substance had crossed a legally defined market-entry threshold: food-additive approval, inclusion in a positive list, a novel-food authorisation, a Generally Recognized as Safe (GRAS) conclusion, a traditional-use pathway, or another recognised legal basis. That architecture remains legally decisive, but it is increasingly insufficient as a description of how modern safety governance actually works. New analytical methods, changing exposure patterns, more complex manufacturing technologies, systematic post-market reassessment, data-rich supply chains and regulatory digitalisation are pushing authorities and industry toward a different operating logic: safety and compliance are becoming continuously defensible evidence positions rather than one-time administrative events. The United States provides the most visible 2026 example. On 10 August 2026 the U.S. Food and Drug Administration (FDA) announced a proposed rule, published in the Federal Register on 11 August 2026 as 91 FR 51834, that would require submission of GRAS notices for certain uses of substances in human and animal food, replacing a major element of the current voluntary notification architecture. The proposal does not abolish GRAS as a statutory concept. Its significance lies elsewhere: it would materially increase regulatory observability of substances entering commerce under GRAS conclusions and would reduce the informational asymmetry created by independent GRAS determinations that never reach FDA. The same agency has also finalised a systematic post-market assessment programme for food chemicals and launched reassessments of selected substances, illustrating that market entry and market permanence are becoming distinct regulatory questions. [1–5] The European Union already operates within a more centralised authorisation architecture, yet its continuing re-evaluation of legacy food additives shows that positive-list systems also require life-cycle governance. As of 10 September 2026, the European Commission reported 315 pre-2009 additives subject to re-evaluation, 245 covered by 137 EFSA opinions and 70 still awaiting completion. Great Britain, meanwhile, has converted regulated-product authorisations into official electronic registers following reforms effective from 1 April 2025, creating a more administratively updateable regulatory infrastructure. [6–10] This article develops the concept of regulatory life-cycle management for food ingredients and analyses its consequences for scientific evidence, manufacturing comparability, biotechnology, data architecture, artificial intelligence, intellectual property, SMEs, international market access and corporate strategy. It proposes several research concepts—regulatory observability, manufacturing drift, evidence readiness, the regulatory digital twin, the regulatory evidence graph and Regulatory Evidence Engineering—and distinguishes clearly between established law, analytical interpretation and prospective research hypotheses.