LegalizeCommission Implementing Regulation (EU) 2022/1421 of 22 August 2022 concerning the authorisation of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck as feed additives for all animal species (Text with EEA relevance)
Current text a fecha 2024-02-05
Article 1
Authorisation
The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
Article 3
Entry 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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 active substance/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 2b143-eo | Expressed orange essential oil | Additive composition Expressed orange essential oil from fruit peels of Citrus sinensis (L.) Osbeck (1). Liquid form Characterisation of the active substance Essential oil derived by cold expression from fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (2). In the volatile fraction: d-Limonene: 93-97 % Myrcene: 1,5-3,5 % Sabinene: 0,1-1,0 % α-Pinene: 0,4-0,8 % Linalool: 0,1-0,7 % Decanal: 0,1-0,7 % Octanal: 0,1-0,6 % Perillaldehyde: < 0,05 % CAS number: 8028-48-6 Einecs number: 232-433-8 FEMA number: 2825 CoE number: 143 Analytical method (3) For the determination of d-limonene (phytochemical marker) in the feed additive: — gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140) | Chickens for fattening and minor poultry species for fattening Laying hens and minor poultry species for laying and breeding Turkeys for fattening | — | — | 80 | 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 with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animal. 4. 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. | 12 September 2032 |
| All Suidae species for fattening | — | — | 172 | |||||
| Piglets of all Suidae species | — | — | 144 | |||||
| Sows of all Suidae species | — | — | 200 | |||||
| Ruminants | — | — | 130 | |||||
| Horses | — | — | 230 | |||||
| Other animal species and categories except dogs, cats, ornamental fish and ornamental birds | — | — | 50 | |||||
| (1) Synonyms: Citrus sinensis (L.) Pers., Citrus aurantium (L.) Dulcis. (2) Natural sources of flavourings – Report No 2 (2007). (3) 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 | ||||||||
| 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 | ||||||||
| 2b143-di | Distilled orange essential oil | Additive composition Distillate (volatile fraction) of orange essential oil, which is obtained from fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Volatile fraction from the distillation of orange essential oil expressed (cold pressed), which is obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (1). d-Limonene: 93-97,5 % Myrcene: 1,5-3,5 % Sabinene: 0,2-1,0 % α-Pinene: 0,3-0,8 % Linalool: 0,05-0,5 % Octanal: 0,05-0,4 % Perillaldehyde: < 0,005 % CAS number: 8028-48-6 CoE number: 143 Analytical method (2) For the determination of d-limonene (phytochemical marker) in the feed additive: — gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140) | Chickens for fattening and minor poultry species for fattening Laying hens and minor poultry species for laying and breeding Turkeys for fattening | — | — | 80 | 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 with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animals. 4. 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. | 12 September 2032 |
| Suidae | — | — | 200 | |||||
| Ruminants | — | — | 130 | |||||
| Horses | — | — | 225 | |||||
| Other animal species and categories except dogs, cats, ornamental fish and ornamental birds | — | — | 80 | |||||
| (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 | ||||||||
| 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 | ||||||||
| 2b143-f | Folded orange oil | Additive composition Folded oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Folded oil produced by the fractional distillation of an expressed orange essential oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (1). Non-volatile fraction: 10,5 % In the volatile fraction: d-Limonene: 89-96 % Decanal: 0,5-2 % Linalool: 0,7-1,7 % Myrcene: 0,1-1,0 % Geranial: 0,1-1,0 % Perillaldehyde: < 0,3 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method (2) For the determination of d-limonene (phytochemical marker) in the feed additive: — gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140) | Chickens for fattening and minor poultry species for fattening | — | — | 15,5 | 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 with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animals. 4. 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. | 12 September 2032 |
| Laying hens and minor poultry species for laying and breeding | — | — | 23,5 | |||||
| Turkeys for fattening | — | — | 21 | |||||
| All Suidae for fattening | — | — | 34 | |||||
| Piglets of all Suidae species | — | — | 28,5 | |||||
| Sows of all Suidae species | — | — | 41,5 | |||||
| Calves (milk replacer) | — | — | 66,5 | |||||
| Sheep and goats Other ruminants for fattening | — | — | 62,5 | |||||
| Dairy ruminants other than dairy sheep and dairy goats | — | — | 40,5 | |||||
| Horses | — | — | 62,5 | |||||
| Rabbits | — | — | 25 | |||||
| Fish except ornamental fish | — | — | 70 | |||||
| Other animal species and categories except dogs, cats, ornamental fish and ornamental birds | — | — | 15,5 | |||||
| (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 | ||||||||
| 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 | ||||||||
| 2b143-f-i | Folded orange oil | Additive composition Folded oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Folded oil produced by the fractional distillation of an expressed orange essential oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (1). Non-volatile fraction: 20,9 % In the volatile fraction: d-Limonene: 79-89 % Decanal: 3,0-5,0 % Linalool: 2,0-5,0 % Myrcene: 0,1-1,0 % Geranial: 0,5-1,8 % Perillaldehyde: < 0,6 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method (2) For the determination of d-limonene (phytochemical marker) in the feed additive: — gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 11024) | Chickens for fattening and minor poultry species for fattening | — | — | 5,5 | 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 with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animals. 4. 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. | 12 September 2032 |
| Laying hens and minor poultry species for laying and breeding | — | — | 8 | |||||
| Turkeys for fattening | — | — | 7 | |||||
| All Suidae for fattening | — | — | 11,5 | |||||
| Piglets of all Suidae species | — | — | 9,5 | |||||
| Sows of all Suidae species | — | — | 14 | |||||
| Calves (milk replacer) | — | — | 23 | |||||
| Sheep and goats Other ruminants for fattening | — | — | 21,5 | |||||
| Dairy ruminants other than dairy sheep and dairy goats | — | — | 14 | |||||
| Horses | — | — | 21,5 | |||||
| Rabbits | — | — | 8,5 | |||||
| Fish except ornamental fish | — | — | 24,5 | |||||
| Other animal species and categories except dogs, cats, ornamental fish and ornamental birds | — | — | 5,5 | |||||
| (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 | ||||||||
| 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 | ||||||||
| 2b143-f-ii | Folded orange oil | Additive composition Folded oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Folded oil produced by the fractional distillation of an expressed orange essential oil which is obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (1). Non-volatile fraction: 18 % In the volatile fraction: d-Limonene: 85-95 % Linalool: 0,5-4 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method (2) For the determination of d-limonene (phytochemical marker) in the feed additive: — gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140) | All animal species except horses, rabbits, 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, laying hens and minor poultry species for laying and breeding, turkeys for fattening, Suidae: 50 mg; — Calves (milk replacer), sheep, goats: 70 mg; — Ruminants except sheep and goats: 60 mg; — Other animal species and categories except horses, rabbits, dogs, cats, ornamental fish and ornamental birds: 2 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. 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. | 12 September 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 |