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Novel food approvals, labelling rules and the regulators setting the pace in each market.
Nine amendments to the EU novel food list this year share a stage no launch plan plots: the months between EFSA publishing an opinion and the Commission adopting a regulation. The seven-month statutory clock starts on a date the regulation never prints — and we got that wrong ourselves.
We said in August we had not read the FDA's letter on GRN 1268 and would not quote what we had not seen. We have now read it. It dates the deficiency email to 11 February 2026 and the withdrawal request to 13 February — day 176 and day 178 of a 180-day clock.
Phytolon's beetroot red became 21 CFR 73.39 on 6 February 2026. One objection filed on 5 March suspended it indefinitely. Colours cannot use the GRAS route at all — FDA says so verbatim in its own protein letters — so the replacement for Red 40 is on a slower clock than the 2026 phase-out it is meant to serve.
GRN 1241 is routinely summarised as clearing beta-lactoglobulin at up to 35%. That ceiling applies to nutritional bars alone. Yogurt is capped at 8% and milk at 6% — and FermWhey Gel, the product Verley says removes casein from spoonable dairy, is not in the notice at all.
dsm-firmenich's Protopia can enter the EU without a novel food authorisation because Ireland ruled Cyberlindnera jadinii not novel under Article 4. Yarrowia lipolytica biomass sits on the same EFSA QPS list with the same qualification, and still took a two-year authorisation.
Fermify's GRN 1228 covered six food categories at up to 15%. It closed at the notifier's request on 13 June 2025 and was never resubmitted. Formo and NewMilkBuzz's GRN 1312 covers cheese analogs alone, at up to 25g per 100g, and the agency's letter line still reads Pending.
Britain published supplementary guidance for precision and biomass fermentation on 20 March 2026. It sets DIAAS as the preferred protein-quality score, INFOGEST as the default method, and around 12% inclusion as the line above which a digestibility assay is expected.
The SFA's first published List of Approved Novel Foods covers 14 products cleared between 21 May 2019 and 17 October 2025. It names no applicants, but it discloses fetal bovine serum in the 2020 cultivated chicken file, and bioreactors of 200 to 20,000 litres with a minimum 30 g/L harvest density for cultured quail.
The Biotech Act proposal opens regulatory sandboxes to food enzymes, additives, processing aids and production processes — then excludes novel foods by name, in Article 56(7). The line is drawn at the regulatory class of the output, not the risk of the process, and eight trade bodies have told the Commission so.
Docket FDA-2025-N-3262, RIN 0910-AJ02, comments close 9 December 2026. There is no grandfathering clause: proposed § 170.205(a) reaches substances already in the food supply. The only relief is a streamlined submission under a new subpart F, open for one year after the final rule takes effect.
The FDA's GRAS inventory holds fifteen lactoferrin notices. None covers recombinant human lactoferrin: the three that ever did, filed 2004 to 2007, were all withdrawn at the notifier's request. Helaina self-affirmed instead — and infant formula is a stricter pathway again.
The FDA inventory lists five cultivated meat clearances. Eight states now prohibit the sale of the products. In March a federal appeals court held that federal inspection law does not stop a state banning a federally cleared meat — and one of the five clearance holders is being auctioned this week.
The Commission adopted the implementing regulation for Fermotein on 3 July 2026, six years after the dossier went in. Four months earlier the FDA closed GRN 1268 at the company's own request, after telling it the notice had deficiencies. The assumption that the US is the fast route just failed a test.
EFSA's register logs the application on 13 February 2026, 387 days after Mosa Meat said it had filed with the Commission — and by 30 June it still had not been validated, so the nine-month assessment clock had not started. Of the 15 dossiers EFSA did validate in H1 2026, one was a precision-fermented protein.
The FSA's £1.6m programme runs to February 2027 with one headline KPI: complete risk assessments for two cell-cultivated product applications. A risk assessment is not market authorisation — and no cell-cultivated product has yet been authorised for human consumption in Great Britain.
Remilk cleared the US in February 2023, Israel three months later, and Singapore alongside them — then withdrew its EU application entirely. One company, four regulators, four outcomes. A practical comparison of launch-market sequencing.
A full accounting of every FDA GRAS clearance for precision-fermented protein since Impossible Foods' 2018 leghemoglobin — updating our earlier count of seven — with the submission-to-clearance timeline for each, and why the pace roughly tripled last year.
Perfect Day's EU dossier died in validation after two years. Remilk withdrew. Neither ever reached scientific assessment. A look at why the Novel Food pathway is pushing food-tech launches out of Europe — and whether the Biotech Act changes anything.