The original 2012 guidance saw only a formatting update in 2021, leaving its scientific content largely unchanged for over a decade despite significant advances in risk assessment science. The 2026 revision integrates EFSA's horizontal guidances developed since then, covering areas such as mixture toxicity, benchmark dose modelling, and the threshold of toxicological concern, and aligns methodologically with the 2022 guidance on flavourings.

Among the changes, applicants must now consider case-by-case environmental assessment triggers, such as bioconcentration potential or persistence in sewage treatment, and follow a tiered toxicological testing approach in which confirmed in vivo genotoxicity halts the assessment pathway entirely. A six-month transitional period gives industry time to adapt to the new requirements.

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