Two new flavouring substances on the EU list: naringenin (FL 16.132) from grapefruit peel, a bitterness masker — in 18 food categories at 200–1,000 mg/kg, purity ≥ 95 % (HPLC), racemate; and the cooling FL 16.134 only in chewing gum up to 100 mg/kg, purity ≥ 99 % (HPLC-UV at 257 nm, diastereomer ratio on a chiral phase)
Commission Regulation (EU) 2025/1112, published on 5 June 2025, enters in Part A of Annex I to Regulation (EC) No 1334/2008 naringenin (FL 16.132, CAS 480-41-1; application of 27 October 2021) and 2-methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2-yl)piperidin-1-yl)butan-1-one (FL 16.134, CAS 2413115-68-9; application of 30 June 2016). In opinions of 20 and 21 March 2024 EFSA found no safety concern for the requested uses — for naringenin also as regards genotoxicity and interaction with medicinal products, for FL 16.134 also combined with exposure from toothpaste and mouthwash.
- Naringenin — limits: 1,000 mg/kg in category 12.2 (herbs, spices, seasonings); 500 mg/kg in 1.4, 1.8 (soy-based only), 12.9, 14.1.4 and 16 (dairy- and soy-based only); 400 mg/kg in 5.1, 5.2, 5.3 and 15.1; 300 mg/kg in 14.1 (non-alcoholic beverages); 200 mg/kg in 1.7, 3, 6.3, 8.2, 8.3, 11.4 and 12.5. According to the applicant it is obtained from grapefruit peel, which contains the glycoside naringin; it is intended as a flavour modifier, in particular a bitterness masker.
- Naringenin — specification (EFSA, FGE.413): identity by IR, ¹H and ¹³C NMR, MS; racemate (chiral centre). Purity in three batches determined by HPLC: 96.1 ± 0.76 %, requirement ≥ 95 %; in an additional batch (98.4 %) impurities — naringenin-7-glucoside with naringin (co-eluted) 0.76 %, apigenin 0.32 %, isosakuranetin 0.53 %. The applicant reported lead, mercury and cadmium, but not arsenic. Estimated intake (APET) 50,000 µg/person per day for adults and 31,500 for children — above the TTC for structural class III.
- Naringenin — toxicology: EFSA requested an extended one-generation reproductive toxicity study (EOGRT), also in view of possible endocrine activity; changes in thymus weight, litter size, post-implantation loss and pup weight in the high-dose F2 generation could not be dismissed, so the NOAEL is 1,320 mg/kg bw per day; margins of exposure 1,590 (adults) and 630 (children). Naringenin inhibits certain CYP450 isoforms (IC₅₀ or Ki of the order of 10 µM); at APET levels EFSA considered a risk of drug interaction unlikely.
- FL 16.134 — category 5.3 (chewing gum) only, up to 100 mg/kg; above that level, according to the applicant, an off-flavour appears. A synthetic substance, a racemic mixture of two diastereomers in ratios between 40/60 and 60/40, determined by HPLC-UV on a chiral phase; sum of stereoisomers ≥ 99 %, other components ≤ 1 % of the HPLC-UV peak area at 257 nm, melting point 155–157 °C; composition confirmed by GC-MS and LC-MS. EFSA (FGE.419): intake 45 µg/person per day (adults) and 28.4 (children), no genotoxicity, BMDL 0.71 mg/kg bw per day for a 20 % increase in relative thyroid (incl. parathyroid) weight in a 90-day rat study; margins 887 and 374.