Commission 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)

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 feed 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 these substances, which are produced and labelled before 12 March 2023 in accordance with the rules applicable before 12 September 2022 may continue to be placed on the market and used until the existing stocks are exhausted. 2.   Compound feed and feed materials containing these substances as specified in the Annex which are produced and labelled before 12 September 2023 in accordance with the rules applicable before 12 September 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for 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 additive/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 other minor poultry species for fattening Laying hens and other minor poultry species for laying and breeding purposes 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 12.9.2032 All Suidae for fattening - - 172 Piglets of all Suidae species - - 144 Sows - - 200 Ruminants - - 130 Horses - - 230 Rabbits Fish except ornamental fish - - 50 Other species - - 50 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 additive/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  ( 4 ) .   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  ( 5 ) 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 other minor poultry species for fattening Laying hens and other minor poultry species for laying and breeding purposes 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 12.9.2032 Suidae - - 200 Ruminants - - 130 Horses - - 225 Rabbits Fish except ornamental fish - - 80 Other species - - 80 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 additive/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  ( 6 ) .   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  ( 7 ) 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 other 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 12.9.2032 Laying hens and other minor poultry species for laying and breeding purposes - - 23,5 Turkeys for fattening - - 21 All Suidae for fattening - - 34 Piglets of all Suidae species - - 28,5 Sows - - 41,5 Calves (milk replacer) - - 66,5 Ruminants for fattening - - 62,5 Dairy ruminants - - 40,5 Horses - - 62,5 Rabbits - - 25 Fish except ornamental fish - - 70 Other species - - 15,5 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 additive/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  ( 8 ) . 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  ( 9 ) 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 other 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 12.9.2032 Laying hens and other minor poultry species for laying and breeding purposes - - 8 Turkeys for fattening - - 7 All Suidae for fattening - - 11,5 Piglets of all Suidae species - - 9,5 Sows - - 14 Calves (milk replacer) - - 23 Ruminants for fattening - - 21,5 Dairy ruminants - - 14 Horses - - 21,5 Rabbits - - 8,5 Fish except ornamental fish - - 24,5 Other species - - 5,5 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 additive/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  ( 10 ) . 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  ( 11 ) 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 - - - 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 other minor poultry species for fattening, laying hens and other minor poultry species for laying and breeding purposes, turkeys for fattening, Suidae : 50 mg; — Calves (milk replacer): 70 mg; — Ruminants except sheep and goats: 60 mg; — Sheep and goats: 70 mg; — Fish, ornamental fish: 2 mg: — Other terrestrial animals: 50 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 12.9.2032 ( 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en ( 4 )   Natural sources of flavourings – Report No 2 (2007). ( 5 )   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 ( 6 )   Natural sources of flavourings – Report No 2 (2007). ( 7 )   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 ( 8 )   Natural sources of flavourings – Report No 2 (2007). ( 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 )   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