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Regulation

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

CELEX
Implementing Regulation (EU) 2024/260
Date of document
Articles
4
Source
EUR-Lex
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.

Schedules & Appendices

ANNEX

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.

4 articles

Cite this act

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 (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32024R0260

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