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Document 02022R1421-20240205

    Consolidated text: 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 certain animal species (Text with EEA relevance)Text with EEA relevance

    ELI: http://data.europa.eu/eli/reg_impl/2022/1421/2024-02-05

    02022R1421 — EN — 05.02.2024 — 001.001


    This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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    ►M1   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 certain animal species ◄

    (Text with EEA relevance)

    (OJ L 218 23.8.2022, p. 27)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2024/239 of 15 January 2024

      L 

    1

    16.1.2024




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    ▼M1

    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 certain animal species

    ▼B

    (Text with EEA relevance)



    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.

    ▼M1

    Article 2

    Transitional measures

    1.  
    The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 5 August 2024 in accordance with the rules applicable before 5 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 5 February 2025 in accordance with the rules applicable before 5 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 5 February 2026 in accordance with the rules applicable before 5 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.

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    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.

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    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

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