Parma: Companies seeking approval for food additives now work under a rewritten evidence standard. The European Food Safety Authority adopted revised guidance on the scientific data required under Regulation 1331/2008 in November 2025, published it on 20 January 2026, and applied it to every application submitted from 20 July onwards.
The guidance covers four areas. Applicants must characterise the substance, describing identity, manufacturing process, specifications, stability, how it behaves and breaks down in food, and the analytical methods used to detect it. They must set out proposed uses and use levels and calculate dietary exposure. They must supply safety data, with genotoxicity handled through a tiered approach before broader toxicology. Where relevant, they must address environmental safety.
The tiered structure is the change with the most practical bite. Under it, an applicant runs an initial battery of tests and only escalates to more demanding studies if the results warrant. Done well, this reduces animal testing and cuts cost for substances that clear early. Done badly, it produces a dossier that stalls when the authority asks for the next tier eighteen months into an assessment, by which point the applicant has already committed to a launch date.
Characterisation requirements have tightened in ways that catch established products. An additive authorised decades ago may have specifications written to the analytical capability of the period. Reopening the file to change a use level now means meeting current standards for identity and purity, and manufacturers have found that older substances do not always document cleanly against modern methods. Several firms have chosen to withdraw minor uses rather than rebuild the evidence.
EFSA allowed a transition. Dossiers already at an advanced stage of preparation before the July date could follow the previous version, which spared companies mid-flight rewrites but also means assessors will handle two standards in parallel for the next few years. That overlap complicates comparisons between decisions taken on either side of the line.
Smaller producers carry the heavier burden. A multinational keeps regulatory scientists who read guidance for a living; a specialist ingredient firm with forty staff does not. EFSA has recognised the imbalance and runs a call for expression of interest in advice aimed at small and medium enterprises and first-time applicants, a service that answers procedural questions before submission rather than after rejection. Uptake has been modest, partly because firms that most need it are the least likely to be watching for it.
Consumer organisations broadly welcome tighter data requirements, arguing that the additive register accumulated approvals under weaker evidence and that reassessment has moved slowly. Industry bodies counter that each additional data layer raises the threshold for innovation, and that reformulating to remove an additive can produce a product with more salt, sugar or fat.
Both positions can hold at once. Better data improves decisions and slows them, and the trade-off falls unevenly across the sector. The published guidance is now the operative document, and companies preparing autumn submissions have no version to fall back on.
