Flavouring FL 16.137 hesperetin dihydrochalcone authorised up to 10 mg/kg in 14 food categories; EFSA based its conclusion on addition solely as a solution in 1,2-propanediol (up to 20 % w/w), which the entry in the list does not contain
Commission Regulation (EU) 2026/175, published on 27 January 2026, enters hesperetin dihydrochalcone (FL No 16.137, CAS 35400-60-3) in the Union list of flavouring substances (Part A of Annex I to Regulation (EC) No 1334/2008) with a limit of 10 mg/kg in 14 food categories. It is based on the EFSA opinion of 23 October 2024 (FGE.420). On 12 February 2026 a corrigendum was published that replaces the whole annex.
- Conditions of use: not more than 10 mg/kg in categories 1.4, 3, 4.2, 5.2, 5.3, 6.3, 7.1, 7.2 (only savoury crackers), 12.2, 12.6, 14.1, 14.2.1, 15.1 and 16 (only dairy, dairy analogues, fruit and vegetable based). The application was submitted on 7 November 2022. EFSA found the use under the proposed conditions to raise no safety concern, and likewise the cumulative exposure with four related compounds from FGE.32 (FL 16.061, 16.109, 16.110, 16.112).
- Manufacture and purity according to EFSA (e9091): the starting material is hesperidin from bitter oranges (Citrus aurantium), converted by hydrolysis and hydrogenation into hesperetin dihydrochalcone with a purity of ≥ 95 % on a dry basis. The applicant’s SEM-EDX analysis indicated that at least 50 % of the particles (by number) have at least one dimension below 500 nm and, within this fraction, more than 10 % of particles have at least one dimension below 250 nm, i.e. the pristine material contains a fraction of small particles, including nanoparticles. Stability in 1,2-propanediol was tested by HPLC-UV (recovery above 89.9 % after 4 weeks at 40 °C).
- Condition in the opinion: the applicant declared that the substance is to be added to food solely as a solution in 1,2-propanediol (up to 20 % w/w), and EFSA — considering a solubility of at least 200 g/L — therefore had no concern about small particles; its final conclusion was worded “under the proposed conditions of use (to be dissolved in 1,2-propanediol up to 20 % w/w prior to its addition to food)”. The entry in the act (PL and EN, also in the corrigendum) does not contain such a condition — the word “propan” does not occur in the text of the act.
- Toxicology (EFSA): no genotoxicity concern; in the 90-day rat study, changes in thyroid hormone levels at all doses (100–1000 mg/kg bw per day) without findings indicative of hypothyroidism — the Panel considered them not adverse; with a reference point of 1000 mg/kg bw per day the margins of exposure are 71 × 10³ (adults) and 28 × 10³ (children). In the Polish version of the act the name appears in two spellings: „hesperytyny” (title and some recitals) and „hesperetyny” (other recitals and the annex); the corrigendum of 12 February 2026 repeats the same wording of the entry in the annex and does not state what it corrects.