New flavouring substance FL 16.136 (3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester) — 1.7 to 20 mg/kg in 13 food categories; EFSA: 16 stereoisomers, a nanoparticle fraction, assessment valid only for a solution in propan-1-ol; 4 CAS numbers corrected alongside
Commission Regulation (EU) 2026/172, published on 27 January 2026, enters in the Union list of flavourings (Part A of Annex I to Regulation (EC) No 1334/2008) the substance FL 16.136 (CAS 1160112-20-8, JECFA 2203) with a reference to the EFSA evaluation, and corrects the CAS numbers of four substances: FL 08.017, 08.127, 16.041 and 16.132. The application was submitted on 16 March 2020; EFSA adopted its opinion (FGE.418) on 16 December 2024 — the applicant was Symrise AG.
- Limits in Annex I: categories 1.7 and 1.8 (in 1.8 only cheese analogues) — up to 6 mg/kg; 2.1, 4.2 (only vegetables), 8.2, 8.3 and 9.2 — up to 8 mg/kg; 10.2, 12.5 and 12.6 — up to 10 mg/kg; 12.2 and 15.1 — up to 20 mg/kg; 14.1 — up to 1.7 mg/kg. Corrected CAS numbers: FL 08.017 — 97-67-6, FL 08.127 — 13794-15-5, FL 16.041 — 150436-68-3, FL 16.132 — 67604-48-2.
- Characterisation according to EFSA: C17H32N2O3, 312.45 g/mol, a pearl-white powder insoluble in water; four asymmetric centres give 16 stereoisomers, of which the process produces four in large excess. Specification: sum of 16 stereoisomers ≥ 98 wt%, sum of the four main ones ≥ 95 wt%, impurities not more than 2.2 % of the total GC-FID peak area. In eight batches (GC with ethyl 3-(cyclohexylcarbamoylamino)propanoate as internal standard) the four main stereoisomers made up 93.5–98.7 %, all of them 98.1–99.9 %; identity by GC, HPLC, GC-MS, LC-MS, FT-IR and ¹H-NMR.
- Residues and degradation: heptane in 13 batches 90–928 mg/kg, MTBE below 10 mg/kg in 10 batches (LOD and LOQ not specified); GC detected menthylamine (0.06 % of peak area) and an isocyanate (0.02 %), explained by degradation during analysis. In a bouillon base at 40 °C the concentration fell from 9.4 to 7.8 mg/L after 12 weeks, while 1.1 mg/L of the acid from ester hydrolysis appeared — the sum stayed constant. The powder contains a nanoparticle fraction (SEM-EDX, d10 of thickness 122–143 nm); dissolution in water at pH 3 and 7 was below the LC-MS LOQ of 5 μg/L after 30 min, so the criterion of 88 % in 30 min was not met.
- EFSA refrained from a nanomaterial assessment because the substance is to be added only as a solution in propan-1-ol (up to 20 % w/w, solubility at least 200 g/L), and stated that its conclusion applies only under these conditions, which should be reflected in the specifications — the entry added to the list contains no such condition. Chronic exposure (APET) 14 and 36 μg/kg bw per day for adults and children, NOAEL from a 90-day rat study 777 mg/kg bw per day, margins of exposure 55 × 10³ and 21 × 10³; Ames test and in vitro micronucleus test negative.