Commission Implementing Regulation (EU) 2024/260 of 12 January 2024 concerning the authorisation of cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, dong quai tincture from Angelica sinensis (Oliv.) Diels, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., asafoetida essential oil from Ferula-assa-foetida L., dill herb essential oil from Anethum graveolens L. and dill tincture from Anethum graveolens L. as feed additives for certain animal species

Authorisation

Article 1

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Transitional measures

Article 2

1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 4 August 2024 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted. 2.   Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 4 February 2025 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3.   Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 4 February 2026 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

ANNEXSupplementary provisions

ANNEX Identification number of the additive 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 /kg of active substance complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds   2b161-eo Cumin essential oil Additive composition Cumin essential oil obtained from fruits of Cuminum cyminum L. Liquid form Characterisation of the active substance Cumin essential oil obtained by steam distillation of fruits of Cuminum cyminum L. as defined by the Council of Europe  ( 1 ) . Specifications — Cuminaldehyde (4-isopropylbenzaldehyde): 15-46 % — γ-Terpinene: 13-32 % — β-Pinene (pin-2(10)-ene):7-20 % — α-Pinene (pin-2(3)-ene) :0,3-2 % — Estragole: maximum 0,05 % — Dillapiole: maximum 0,05 % CAS number: 8014-13-9 FEMA number: 2343 CoE number: 161 Analytical method  ( 2 ) For the determination of alpha-pinene and cuminaldehyde (phytochemical markers) in the feed additive: gas chromatography coupled to flame ionisation detection (GC-FID) All animal species - - 15 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. Mixture of cumin essential oil with other botanical additives is permitted provided that the amounts of estragole and dillapiole in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method. Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authori-sation mg /kg of active substance complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b200-t Sweet fennel tincture Additive composition Sweet fennel tincture obtained from the dried fruit of Foeniculum vulgare Mill. ssp. vulgare var. dulce Liquid form Characterisation of the active substance Sweet fennel tincture obtained from. the dried fruit of Foeniculum vulgare Mill. ssp. vulgare var. dulce by extended extraction with water/ethanol solvent as defined by the Council of Europe  ( 3 ) . Specifications Dry matter content: maximum 3 % — Total polyphenols: 0,05-0,07 % — Flavonoids: 0,004-0,007 % — Anisaldehyde: 0,003-0,005 % — Anethole: 0,0005-0,0007 % — Estragole: maximum 0,0006 % FEMA number: 2482 CoE number: 200 Analytical method  ( 4 ) For the characterisation of the feed additive: — spectrophotometry for the determination of total polyphenols, and high performance thin-layer chromatography (HPTLC) for the determination of total flavonoids and the phytochemical marker anisaldehyde All animal species except horses Horses - - 50 200 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. Mixture of sweet fennel tincture with other botanical additives is permitted provided that the amounts of estragole in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method. Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authori-sation mg active substance /kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b92456-t Dong quai tincture Additive composition Dong quai tincture obtained from the roots of Angelica sinensis (Oliv.) Diels Liquid form Characterisation of the active substance Dong quai tincture obtained from the roots of Angelica sinensis (Oliv.) Diels by extraction with water/ethanol solvent as defined by the Council of Europe  ( 5 ) . Specifications Dry matter content: maximum 10 % — Ferulic acid: 0,004-0,007 % — Chlorogenic acid: 0,001-0,006 % — Safrole: maximum 0,0001 % — Furocoumarins: maximum 0,0001 % Analytical method  ( 6 ) For the determination of ferulic acid and chlorogenic acid (phytochemical markers) in the feed additive: high performance liquid chromatography coupled with diode array detection (HPLC-DAD) Horses Dogs Cats - - 123 481 184 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. Mixture of dong quai tincture with other botanical additives is permitted provided that the amounts of furocoumarins and safrole in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method. Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authori-sation mg active substance /kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b2835-t Parsley tincture Additive composition Parsley tincture obtained from the seeds of Petroselinum crispum (Mill.) Fuss Liquid form Characterisation of the active substance Parsley tincture obtained from the seeds of Petroselinum crispum (Mill.) Fuss by extended extraction with water/ethanol solvent as defined by the Council of Europe  ( 7 ) . Specifications Dry matter content: maximum 0,9 % — Total polyphenols: 0,018-0,022 % — Total flavonoids: 0,004-0,012 % — Apiole: maximum 0,0092 % — Elemicin: maximum 0,0016 % — Myristicin: maximum 0,0011 % FEMA number:2835  ( 8 ) Analytical method  ( 9 ) For the characterisation of the feed additive: — spectrophotometry for the determination of total polyphenols and — high performance thin-layer chromatography (HPTLC) for the determination of total flavonoids, myristicin and apiole . All animal species except horses Horses - - 50 200 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. Mixture of parsley tincture with other botanical additives is permitted provided that the amounts of apiole, elemicin and myristicin in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method. Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authori-sation mg active substance /kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b2095-t Star anise tincture Additive composition Star anise tincture obtained from the fruit (pericarp and seeds) of Illicium verum Hook f. Liquid form Characterisation of the active substance Star anise tincture obtained from the fruit (pericarp and seeds) of Illicium verum Hook f. by extended extraction with water/ethanol solvent as defined by the Council of Europe  ( 10 ) Specifications Dry matter content: maximum 2,2 % — Total polyphenols: 0,21-0,31 % — Total flavonoids: 0,022-0,024 % — Rutin: 0,0024–0,0044 % — Anethole: 0,0172–0,0182 % — Estragole: maximum 0,00039 % — Safrole: maximum 0,0010 % FEMA number:2095  ( 11 ) Analytical method  ( 12 ) For the characterisation of the feed additive: — spectrophotometry for the determination of total polyphenols and — high performance thin-layer chromatography (HPTLC) for the determination of total flavonoids and anethole All animal species except horses Horses - - 50 200 — The additive shall be incorporated into the feed in the form of a premixture. — In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. — Mixture of star anise tincture with other botanical additives is permitted provided that the amounts of estragole and safrole in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category. — For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 Identification number of the additive 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 2b196-eo Asafoetida essential oil Additive composition Asafoetida essential oil obtained from the rhizome of Ferula-assa-foetida L. Liquid form Characterisation of the active substance Asafoetida essential oil obtained by steam distillation of dried gum resin of the cut rhizome of Ferula assa-foetida L. as defined by the Council of Europe  ( 13 ) . Specifications — (E)-2-Butyl 3-(methylthio)-2-propenyl disulfide: 20-45 % — (E)-sec-Butyl propenyl disulfide: 8-25 % — (Z)-sec-Butyl propenyl disulfide: 8-24 % — Di-sec-Butyl disulfide: 4-16 % CAS number: 9000-04-8 FEMA number: 2108 CoE number: 196 Analytical method  ( 14 ) For the determination of (E)-sec-butyl propenyl disulfide (phytochemical marker) in the feed additive: gas chromatography coupled to flame ionisation detection (GC-FID) Cats 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 %: — 1,5 mg for dogs — 0,2 mg for cats” 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. — For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method. Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authori-sation mg active substance /kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b42-eo Dill herb essential oil Additive composition Dill herb essential oil obtained from stems and leaves of Anethum graveolens L. Liquid form Characterisation of the active substance Dill herb essential oil obtained from stems and leaves of Anethum graveolens L. by steam distillation as defined by the Council of Europe  ( 15 ) . Specifications — Carvone: 28-45 % — Limonene: 16-35 % — α-Phellandrene: 16-31 % — Dill ether (3,6-Dimethyl-2,3,3a,4,5,7a-hexahydrobenzofuran): 4-9 % — Estragole: maximum 0,0003 % — Myristicin: maximum 0,005 % — Apiole: maximum 0,0003 % — Dillapiole: maximum 0,01 % CAS number:8006-75-5 FEMA number: 2383 CoE number: 42 Analytical method  ( 16 ) For the determination of carvone (phytochemical marker) in the feed additive: gas chromatography coupled to flame ionisation detection (GC-FID) Dogs Cats - - - 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 %: — 7 mg for dogs — 5 mg for cats” 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. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method. Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authori-sation mg active substance /kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b42-t Dill tincture Additive composition Dill tincture obtained from the fruit of Anethum graveolens L. Liquid form Characterisation of the active substance Dill tincture obtained from the dried fruit of Anethum graveolens L. by extended extraction with a water/ethanol solvent as defined by the Council of Europe  ( 17 ) . Specifications Dry matter content: maximum 1,1 % — Total polyphenols: 0,02-0,03 % — Flavonoids:0,01-0,02 % — Carvone: 0,001-0,005 % — Estragole: maximum 1,2 mg/kg FEMA number: 2382 CoE number: 42 Analytical method  ( 18 ) For the characterisation of the feed additive (dill tincture): — spectrophotometry for the determination of total polyphenols and — high performance thin-layer chromatography (HPTLC) for the determination of total flavonoids and the phytochemical marker carvone All animal species except horses Horses - - 50 200 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. Mixture of dill tincture with other botanical additives is permitted provided that the amounts of estragole in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 4.2.2034 ( 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. ( 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. ( 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. ( 7 )   Natural sources of flavourings – Report No 2 (2007). ( 8 )   This number corresponds to parsley. ( 9 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. ( 10 )   Natural sources of flavourings – Report No 2 (2007). ( 11 )   This number corresponds to star anise. ( 12 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. ( 13 )   Natural sources of flavourings – Report No 2 (2007). ( 14 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. ( 15 )   Natural sources of flavourings – Report No 2 (2007). ( 16 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. ( 17 )   Natural sources of flavourings – Report No 2 (2007). ( 18 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.