The European Food Safety Authority (EFSA) concluded that the flavouring substances 2-phenylcrotonaldehyde [FL-no: 05.062] and 5-methyl-2-phenylhex-2-enal [FL-no: 05.099] do not raise a genotoxicity concern under specified use levels, according to a scientific opinion published on 2 July 2026. For 2-phenylcrotonaldehyde, EFSA determined that use levels not exceeding 2 mg/kg or mg/L in foods and beverages would not raise a concern for aneugenicity, based on a comparison of the lowest aneugenic concentration in an in vitro micronucleus assay (20 μg/mL) with reported use levels (up to 2 mg/kg). For 5-methyl-2-phenylhex-2-enal, the Panel concluded that there is no concern for genotoxicity based on new data.
The opinion, adopted on 29 May 2026 by EFSA's Panel on Food Additives and Flavourings (FAF), is the third revision of Flavouring Group Evaluation 216 (FGE.216Rev3). It addresses subgroup 3.3 of FGE.19, which covers α,β-unsaturated 2-phenyl-2-alkenals. In the previous revision (FGE.216Rev2, June 2022), EFSA had identified an aneugenic potential for five substances, including the two now assessed, and requested substance-specific data. Three other substances from the subgroup (FL-no: 05.100, 05.175, and 05.222) were flagged for deletion from the EU Union List after applicants indicated they would no longer support their evaluation. In May 2024, applicants submitted new data for the two substances now cleared.
The evaluation follows a long-standing EFSA process for α,β-unsaturated carbonyls, which are structural alerts for genotoxicity. Since 2008, EFSA has subdivided these substances into subgroups and requested genotoxicity data. For subgroup 3.3, 2-phenylcrotonaldehyde was selected as the representative substance for testing. The new data included a plasma analysis from animals administered 2-phenylcrotonaldehyde, which ruled out systemic aneugenicity, but the Panel noted that concern at the site of contact remained. By comparing the in vitro aneugenic concentration with maximum use levels, the Panel set a safe threshold of 2 mg/kg. For 5-methyl-2-phenylhex-2-enal, new genotoxicity tests showed no concern.
The opinion impacts food manufacturers using these flavourings, as it provides a clear safety threshold for 2-phenylcrotonaldehyde and confirms the safety of 5-methyl-2-phenylhex-2-enal. EU regulators may use the findings to update the Union List of flavourings. Consumers benefit from continued access to these flavourings with assured safety. The three substances withdrawn from the market will not be reassessed. The European Commission requested the evaluation under Regulation (EC) No 1334/2008, and EFSA's conclusion allows the substances to proceed to full safety evaluation under the Procedure for flavouring substances.