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 2b489-eo - Ginger essential oil Additive composition Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe. Characterisation of the active substance Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe ( 1 ) . — α-zingiberene: 29-40 % — β-sesquiphellandrene: 8-14 % — ar-curcumene: 5-12 % — α-farnesene: 4-10 % — camphene: 2-10 % — β-bisabolene: 2-9 % CAS number: 8007-08-7 Einecs number: 283-634-2 FEMA number: 2522 CoE number: 489 Liquid form Analytical method ( 2 ) For the quantification of alpha-zingiberene, beta-sesquiphellandrene and ar-curcumene in the feed additive: — Gas chromatography coupled to mass spectrometry (GC-MS) (full scan mode) using Retention Time Locking (RTL) methodology (or standard substances of the phytochemical markers) with (or without) gas chromatography coupled to flame ionisation detection (GC-FID) based on the ISO 11024 standard method. All animal species - - - 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 %: — veal calves (milk replacer): 80 mg; — other species or categories of animals: 20 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. The mixture of ginger essential oil with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs. 6. 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 eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 12.4.2031 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 2b489-or - Ginger oleoresin Additive composition Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe. Characterisation of the active substance Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe ( 3 ) . Essential oil: 25-30 (w/w) Total gingerols: 0,5-8 % (w/w) — 6-Gingerol — 8-Gingerol — 10-Gingerol Total shogaols: 3-6 % (w/w) — 6-Shogaol — 8-Shogaol Humidity and volatiles: 25-30 (w/w) CoE number: 489 Liquid form Analytical method ( 4 ) For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger oleoresin): — High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685 Chickens for fattening Laying hens Turkeys for fattening Piglets Pigs for fattening Sows Dairy cows Veal calves (milk replacers) Cattle for fattening Sheep and goats Horses Rabbits Fish Pets - - - 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 % and for milk replacers with a moisture content of 5,5 %: — chickens for fattening: 5 mg; — laying hens and rabbits: 7 mg; — turkeys for fattening: 6 mg; — piglets: 8 mg; — pigs for fattening: 10 mg; — sows: 13 mg; — dairy cows: 12 mg; — veal calves (milk replacers): 21 mg; — cattle for fattening: 19 mg; — sheep, goats, horses and fish: 20 mg; — pets: 1 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. The mixture of ginger oleoresin with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs. 6. 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 eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 12.4.2031 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 2b489-t - Ginger tincture Additive composition Ginger tincture obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture. Characterisation of the active substance Ginger tincture is obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture as defined by the Council of Europe ( 5 ) . Solvent (ethanol/water, 90/10): 97-98 % (w/w) Dry matter: 2-3 % (w/w) Total gingerols: 0,14-0,11 % (w/w) — 6-Gingerol — 8-Gingerol — 10-Gingerol Total shogaols: 0,043-0,031 % (w/w) — 6 Shogaol — 8-Shogaol Analytical method ( 6 ) For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger tincture): — High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685 Horses Dogs - - - 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 %: — Horses 1,58 mL — Dogs 1,81 mL’. 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. The mixture of ginger tincture with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs. 6. 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 eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 12.4.2031 ( 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 ( 3 ) Natural sources of flavourings – Report No 2 (2007). ( 4 ) 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 ( 5 ) Natural sources of flavourings – Report No 2 (2007). ( 6 ) 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