New flavouring substance FL 16.135 — a synthetic amide with a cooling effect — on the Union list: confectionery up to 250 mg/kg, chewing gum up to 500 mg/kg, decorations and toppings up to 150 mg/kg; EFSA — purity determined by GC-FID and HPLC-UV at 280 nm, recommended minimum 98 %, BMDL 101 mg/kg bw per day
Commission Regulation (EU) 2025/140, published on 30 January 2025, enters (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide (FL No 16.135, CAS 1309389-73-8) in Part A of Annex I to Regulation (EC) No 1334/2008 — the Union list of flavouring substances. The application was submitted on 15 January 2019; in its opinion of 18 May 2022 EFSA found no safety concern at the estimated intake, also combined with exposure from toothpaste, in which the substance is already used.
- Conditions of use (food categories of Annex II to Regulation 1333/2008): category 5 other than 5.1, 5.3 and 5.4 (confectionery, including hard and soft candy, nougats) — up to 250 mg/kg; 5.3 (chewing gum) — up to 500 mg/kg; 5.4 (decorations, non-fruit toppings, sweet sauces) — up to 150 mg/kg. The applicant withdrew the uses in soft drinks and beer reported earlier. The substance does not occur naturally in food; it is synthesised and, according to the applicant, gives a cooling effect with minty, burning, tingling, fresh and fruity notes.
- Specification (EFSA): colourless crystals, a white powder when ground, melting point 145 °C; identity by GC, HPLC, IR, NMR and MS. Purity was determined by GC with flame ionisation detection (area percentages without correction factors) and by HPLC with UV detection at 280 nm. The applicant proposed > 95 % with the impurities 3,4-(methylenedioxy)cinnamic acid < 3 % and the (Z)-isomer < 3 %; after process optimisation batches exceed 99 %, so EFSA agreed to a minimum of 98 % without separate impurity limits. Formally it is a derivative of 2-propenamide (acrylamide), but acrylamide is not used in the synthesis.
- Physical properties relevant to analysis: water solubility 0.124 mg/L at 20 °C (OECD TG 105), in ethanol above 2 %; the neat substance is stable for at least 8 months at room temperature, but in concentrated organic solutions exposed to light it isomerises (double bond), so solutions are stored in the dark. Hydrolysis of the amide requires strongly acidic or alkaline conditions and high temperature, so EFSA does not expect degradation in foods of the requested categories.
- EFSA assessment (FAF Panel, FGE.415): intake by the APET method 780 µg/person per day (60 kg adult) and 480 µg/person per day (15 kg child); no genotoxicity in bacterial mutation and in vitro micronucleus tests; no developmental toxicity in rats up to 1,000 mg/kg bw per day. A BMDL of 101 mg/kg bw per day was derived from the decrease in white blood cell count in females in the 90-day study (JECFA had earlier used a NOAEL of 490 mg/kg bw per day); margins of exposure 7,800 for adults and 3,200 for children. From toothpaste (200–800 ppm) exposure is 28–112 µg/person per day.