ANNEX IISupplementary provisions
ANNEX II Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method. Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg active substance/kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b136-ex — Bitter orange extract Additive composition Bitter orange extract from the fruit of Citrus x aurantium L. Solid form Characterisation of the active substance Bitter orange extract from the fruit of Citrus x aurantium L. as defined by the Council of Europe ( 1 ) . Flavonoids: 45-55 % of which — Naringin: 20-30 % — Neohesperidin: 10-20 % 5-methoxypsoralen (also known as bergapten): ≤ 0,03 % (-)-Synephrine: ≤ 1 % CoE number: 136 Analytical method ( 2 ) For the quantification of naringin (phytochemical marker) in the feed additive: — High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection All animal species except dogs, cats, ornamental fish and ornamental birds — — 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: — Chickens for fattening and minor poultry species for fattening: 102 mg; — Laying hens and minor poultry species for laying or breeding: 151 mg; — Turkeys for fattening: 136 mg; — Piglets of all Suidae species : 182 mg; — All Suidae for fattening: 217 mg; — Sows of all Suidae species : 268 mg; — Dairy ruminants other than dairy sheep and dairy goats: 259 mg; — Calves (milk replacer), sheep, goats, other ruminants for fattening, horses, salmonids and all other fin fish: 400 mg; — Rabbits: 161 mg; — Other animal species and categories except dogs, cats, ornamental fish and ornamental birds: 102 mg’. 4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. 5. Mixture of bitter orange extract with other botanical additives is permitted provided that the amounts of 5-methoxypsoralen and (-)-synephrine in feed materials and compound feed are lower than the ones resulting from the use of a single additive at the maximum or recommended level for the species or animal category. 6. The mixture of bitter orange extract from the fruit of Citrus x aurantium L. with other authorised additives obtained from Citrus aurantium L. shall not be allowed in feedingstuffs. 7. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 11 May 2032 ( 1 ) Natural sources of flavourings – Report No 2 (2007). ( 2 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports