Clove tincture (2b188-t) as a flavouring in feed until 5 March 2035: 50 mg/kg for all species except equines and 200 mg/kg for equines, not in drinking water; GC-FID for eugenol, methyleugenol (≤ 0.00022 %) and estragole (≤ 0.00009 %), polyphenols by spectrophotometry
Commission Implementing Regulation (EU) 2025/276, published on 13 February 2025, following a re-evaluation authorises a tincture of dried clove flower buds (Syzygium aromaticum) as a sensory additive for all animal species; it had previously been authorised under Directive 70/524/EEC. Use in drinking water was not authorised, because Regulation (EC) No 1831/2003 does not provide for this for flavouring compounds. The Commission relies on the EFSA opinion of 17 April 2024 and, because of methyleugenol and estragole, sets maximum contents in feed.
- Annex: a tincture as defined by the Council of Europe (CoE No 188) from dried flower buds of Syzygium aromaticum (synonym Eugenia caryophyllata), obtained by extended extraction with water and ethanol, pressing and filtration; liquid form. Specification: dry matter 1.57–1.77 %, total polyphenols ≤ 0.541 % (as gallic acid equivalent), flavonoids ≤ 0.0418 %, eugenol ≤ 0.00497 %, eugenyl acetate < 0.00017 mg/mL, methyleugenol ≤ 0.00022 %, estragole ≤ 0.00009 %. Methods: spectrophotometry for polyphenols and flavonoids, GC-FID for eugenol (phytochemical marker), estragole, methyleugenol and eugenyl acetate.
- EFSA data (five batches): dry matter on average 1.66 %, solvent 98.3 %, density 977 kg/m³, pH 4.60; polyphenols by the Folin–Ciocalteu method (at 760 nm, in-house method based on Ph. Eur. 2.8.14) 0.476–0.541 %, flavonoids at 415 nm 0.0284–0.0418 %, eugenol (GC-FID) 0.0296–0.0497 %, methyleugenol 1.64–2.25 mg/kg, estragole 0.62–0.92 mg/kg, eugenyl acetate below the LOD. The annex of the act (also in the EN and DE versions) gives eugenol as “≤ 0.00497 %”, i.e. ten times less than EFSA’s highest result. The EU reference laboratory additionally recommended HPTLC for determining gallic acid.
- Safety (EFSA): methyleugenol and estragole are genotoxic carcinogens of the p-allylalkoxybenzene group; with the reference point BMDL10 of 22.2 mg/kg bw per day the combined margin of exposure is at least 1 500 000 (low-concern threshold: 10 000). The safe concentration of eugenol in feed (NOAEL 300 mg/kg bw per day, an additional factor of 5 for cats) starts at 26 mg/kg for cats, while the tincture contributes at most 0.025 mg/kg (0.099 mg/kg in horses). For polyphenols the margin of exposure is above 17 000 (NOAEL 412 mg GAE/kg bw per day from a 90-day study with the extract Clovinol). EFSA recommended including limits for methyleugenol and estragole in the specification — the act adopts them.
- Conditions: the additive is incorporated into feed as a premixture; mixing with other botanical additives is permitted if the amounts of methyleugenol and estragole do not exceed those resulting from the use of a single additive at the highest rate. EFSA considered the tincture irritant to skin and eyes and a skin and respiratory sensitiser — where procedures are not sufficient, skin, eye and respiratory protection. Transitional period: additive and premixtures produced before 5 September 2025, feed for food-producing animals — before 5 March 2026, for others — before 5 March 2027.