Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionnote, and in particular Article 9(2) thereof,Whereas:
(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECnote.
(2)The substances cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., dill tincture from Anethum graveolens, dong quai tincture from Angelica sinensis (Oliv.) Diels, asafoetida essential oil from Ferula-assa-foetida L., and dill herb essential oil from Anethum graveolens L. were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These substances were subsequently entered in the Register of Feed Additives as existing products belonging to the category ‘sensory additives’ and to the functional group ‘flavouring compounds’, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.
(3)In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., dill tincture from Anethum graveolens, dong quai tincture from Angelica sinensis (Oliv.) Diels, asafoetida essential oil from Ferula-assa-foetida L., and dill herb essential oil from Anethum graveolens L. for all animal species, requesting the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant subsequently withdrew the application for authorisation of dong quai tincture from Angelica sinensis (Oliv.) Diels as regards the use for all animal species except poultry, horses dogs and cats, for authorisation of asafoetida essential oil from Ferula-assa-foetida L. as regards the use for all animal species except dogs and cats and for authorisation of dill herb essential oil from Anethum graveolens L. as regards all animal species except dogs and cats.
(4)The applicant requested the additives to be authorised for use also in water for drinking. In addition, for dong quai tincture from Angelica sinensis (Oliv.) Diels the request for authorisation for poultry was only for a use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of those additives in water for drinking should not be allowed.
(5)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 22 November 2022note that, under the proposed conditions of use, 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., dill herb essential oil from Anethum graveolens L. and dill tincture from Anethum graveolens L., are safe for the target species, consumers and the environment. As regards asafoetida essential oil from Ferula-assa-foetida L., the Authority considered that the substance is safe for dogs and cats and that there is no evidence of concern for the environment. The Authority also concluded that dill herb essential oil, cumin essential oil, dill tincture, sweet fennel tincture, asafoetida oil, dong quai tincture, parsley tincture and star anise tincture should be considered as irritant to skin and eyes, and as dermal and respiratory sensitisers. The Authority concluded that when handling the cumin essential oil, dill herb essential oil, dill tincture, sweet fennel tincture and star anise tincture, exposure of unprotected users to estragole (and dillapiole) cannot be excluded and that therefore, to reduce the risk, the exposure of the users should be minimised. In addition, the Authority concluded that when handling parsley tincture, the exposure of unprotected users to apiole, elemicin and myristicin cannot be excluded and that therefore, to reduce the risk, the exposure of the users should be minimised. The Authority further concluded that since the substances are recognised to flavour food and since their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6)In view of the above, the Commission considers that 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 oil from Ferula-assa-foetida L., dill herb essential oil from Anethum graveolens L. and dill tincture from Anethum graveolens L. satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 for certain animal species. Accordingly, the use of these substances should be authorised for those animal species. The Commission considers that safety reasons do not require the setting of maximum contents for asafoetida essential oil from Ferula-assa-foetida L. and for dill herb essential oil from Anethum graveolens L.. The large margin of exposure and the lack of substances of concern permit to establish maximum recommended contents. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additives. Where such contents are exceeded, certain information should be indicated on the label of the premixtures concerned. For cumin essential oil from Cuminum cyminum L., sweet fennel tincture from Foeniculum vulgare Mill. ssp. vulgare var. dulce, parsley tincture from Petroselinum crispum (Mill.) Fuss, star anise tincture from Illicium verum Hook f., dong quai tincture from Angelica sinensis (Oliv.) Diels and dill tincture from Anethum graveolens L., the Commission considers that the presence of substances of concern requires to set a maximum content in complete feed and to limit the combination of these additives with others containing the same substances of concern. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives.
(7)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
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.
Article 2Transitional measures#
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.
Article 3Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| 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 compositionCumin essential oil obtained from fruits of Cuminum cyminum L.Liquid formCharacterisation of the active substanceCumin essential oil obtained by steam distillation of fruits of Cuminum cyminum L. as defined by the Council of Europenote.SpecificationsCuminaldehyde (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: 8014-13-9FEMA number: 2343CoE number: 161Analytical methodnoteFor 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 compositionSweet fennel tincture obtained from the dried fruit of Foeniculum vulgare Mill.ssp. vulgare var. dulceLiquid formCharacterisation of the active substanceSweet 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 Europenote.SpecificationsDry 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: 2482CoE number: 200Analytical methodnoteFor the characterisation of the feed additive:spectrophotometry for the determination of total polyphenols, andhigh performance thin-layer chromatography (HPTLC) for the determination of total flavonoids and the phytochemical marker anisaldehyde | All animal species except horsesHorses | - | - | 50200 | 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 compositionDong quai tincture obtained from the roots of Angelica sinensis (Oliv.) DielsLiquid formCharacterisation of the active substanceDong quai tincture obtained from the roots of Angelica sinensis (Oliv.) Diels by extraction with water/ethanol solvent as defined by the Council of Europenote.SpecificationsDry 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 methodnoteFor 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) | HorsesDogsCats | - | - | 123481184 | 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 compositionParsley tincture obtained from the seeds of Petroselinum crispum (Mill.) FussLiquid formCharacterisation of the active substanceParsley tincture obtained from the seeds of Petroselinum crispum (Mill.) Fuss by extended extraction with water/ethanol solvent as defined by the Council of Europenote.SpecificationsDry 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:2835noteAnalytical methodnoteFor the characterisation of the feed additive:spectrophotometry for the determination of total polyphenols andhigh performance thin-layer chromatography (HPTLC) for the determination of total flavonoids, myristicin and apiole . | All animal species except horsesHorses | - | - | 50200 | 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 compositionStar anise tincture obtained from the fruit (pericarp and seeds) of Illicium verum Hookf.Liquid formCharacterisation of the active substanceStar anise tincture obtained from the fruit (pericarp and seeds) of Illicium verum Hookf. by extended extraction with water/ethanol solvent as defined by the Council of EuropenoteSpecificationsDry 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:2095noteAnalytical methodnoteFor the characterisation of the feed additive:spectrophotometry for the determination of total polyphenols andhigh performance thin-layer chromatography (HPTLC) for the determination of total flavonoids and anethole | All animal species except horsesHorses | - | - | 50200 | 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 compositionAsafoetida essential oil obtained from the rhizome of Ferula-assa-foetida L.Liquid formCharacterisation of the active substanceAsafoetida 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 Europenote.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: 9000-04-8FEMA number: 2108CoE number: 196Analytical methodnoteFor the determination of (E)-sec-butyl propenyl disulfide (phytochemical marker) in the feed additive: gas chromatography coupled to flame ionisation detection (GC-FID) | CatsDogs | - | - | - | 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 dogs0,2 mg for cats4. 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 compositionDill herb essential oil obtained from stems and leaves of Anethum graveolens L.Liquid formCharacterisation of the active substanceDill herb essential oil obtained from stems and leaves of Anethum graveolens L. by steam distillation as defined by the Council of Europenote.SpecificationsCarvone: 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:8006-75-5FEMA number: 2383CoE number: 42Analytical methodnoteFor the determination of carvone (phytochemical marker) in the feed additive: gas chromatography coupled to flame ionisation detection (GC-FID) | DogsCats | - | - | - | 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 dogs5 mg for cats4. 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 compositionDill tincture obtained from the fruit of Anethum graveolens L.Liquid formCharacterisation of the active substanceDill tincture obtained from the dried fruit of Anethum graveolens L. by extended extraction with awater/ethanol solvent as defined by the Council of Europenote.SpecificationsDry 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/kgFEMA number: 2382CoE number: 42Analytical methodnoteFor the characterisation of the feed additive (dill tincture):spectrophotometry for the determination of total polyphenols andhigh performance thin-layer chromatography (HPTLC) for the determination of total flavonoids and the phytochemical marker carvone | All animal species except horsesHorses | - | - | 50200 | 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 |
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