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Commission Implementing Regulation (EU) 2024/239of 15 January 2024correcting and amending Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320(Text with EEA relevance)

Den Europæiske UnionForordning2024

European Union

Commission Implementing Regulation (EU) 2024/239 of 15 January 2024 correcting and amending Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320 (Text with EEA relevance) 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 nutrition OJ L 268, 18.10.2003, p. 29. , and in particular Article 9(2) thereof, Whereas: (1) The use of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck as feed additives was authorised for all animal species by Commission Implementing Regulation (EU) 2022/1421 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 (OJ L 218, 23.8.2022, p. 27). for a 10-year period. In Article 2 of Implementing Regulation (EU) 2022/1421, transitional measures concerning feed materials and compound feed containing the additives concerned and which are intended for non-food producing animals were erroneously omitted. Furthermore, in its opinion of 29 September 2021 Safety and efficacy of feed additives consisting of expressed sweet orange peel oil and its fractions from Citrus sinensis (L.) Osbeck for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(11):6891. doi: org/10.2903/j.efsa.2021.6891). , the European Food Safety Authority (the Authority) could not conclude on the safety of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck as feed additives for dogs, cats, ornamental fish and ornamental birds, because they are not normally exposed to citrus by-products. The Authority also clarified that folded orange oil identified as 2b143-f-ii in the Annex to Implementing Regulation (EU) 2022/1421 is not intended for use in horses, rabbits, dogs, cats, ornamental fish and ornamental birds. Those species should therefore not have been included in the column species or category of animal of the Annex to Implementing Regulation (EU) 2022/1421 in relation to the additives concerned. The title of Implementing Regulation (EU) 2022/1421 should be adjusted accordingly to reflect the fact that the authorisation of the additives concerned relates to certain animal species only. (2) The use of bitter orange extract as a feed additive was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/652 Commission Implementing Regulation (EU) 2022/652 of 20 April 2022 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (OJ L 119, 21.4.2022, p. 74). for a 10-year period. In its opinion of 23 June 2021 Safety and efficacy of a feed additive consisting of a flavonoid-rich dried extract of Citrus x aurantium L. fruit (bitter orange extract) for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(7):6709. doi: 10.2903/j.efsa.2021.6709).

, the Authority could not conclude on the safety of bitter orange extract as a feed additive for dogs, cats and ornamental fish, because they are not normally exposed to citrus by-products. In addition, an entry covering other animal species than those mentioned in the Annex to Implementing Regulation (EU) 2022/652 was erroneously omitted. Therefore, the column species or category of animal of the Annex to Implementing Regulation (EU) 2022/652 should refer to all animal species except dogs, cats, ornamental fish as well as ornamental birds, which are also not normally exposed to citrus by-products according to the conclusions of the Authority in its opinion of 29 September 2021. (3) The use of expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil as feed additives was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/1490 Commission Implementing Regulation (EU) 2022/1490 of 1 March 2022 concerning the authorisation of expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil as feed additives for certain animal species (OJ L 234, 9.9.2022, p. 1). for a 10-year period. In its opinion of 18 March 2021 Safety and efficacy of feed additives consisting of expressed lemon oil and its fractions from Citrus limon (L.) Osbeck and of lime oil from Citrus aurantiifolia (Christm.) Swingle for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(4):6548. doi: org/10.2903/j.efsa.2021.6548). , the Authority could not conclude on the safety of expressed lemon oil and its residual fraction and of lime oil as feed additives for companion animals and ornamental fish, because they are not normally exposed to citrus by-products. Ornamental fish should therefore not have been included in the column species or category of animal of the Annex to Implementing Regulation (EU) 2022/1490 for the additive identified as 2b141-eo. In addition, an entry covering other animal species except dogs, cats, ornamental fish, as well as ornamental birds, which are also not normally exposed to citrus by-products according to the conclusions of the Authority in its opinion of 29 September 2021, was erroneously omitted and should therefore be included in the column species or category of animal of the Annex to Implementing Regulation (EU) 2022/1490 for the additives identified as 2b139-eo, 2b139-rf and 2b141-eo. Finally, an entry covering other animal species was erroneously omitted and should therefore be included in the column species or category of animal of the Annex to Implementing Regulation (EU) 2022/1490 for the additive identified as 2b139-di. (4) The use of expressed mandarin essential oil as a feed additive was authorised for poultry, pigs, ruminants, horses, rabbits and salmonids by Commission Implementing Regulation (EU) 2022/320

Commission Implementing Regulation (EU) 2022/320 of 25 February 2022 concerning the authorisation of expressed mandarin essential oil as a feed additive for poultry, pigs, ruminants, horses, rabbits and salmonids (OJ L 55, 28.2.2022, p. 41). for a 10-year period. In Article 2 of Implementing Regulation (EU) 2022/320, transitional measures concerning feed materials and compound feed containing the additive concerned and which are intended for non-food producing animals were erroneously omitted. Furthermore, an entry covering other animal species was erroneously omitted in the column species or category of animal of the Annex to Implementing Regulation (EU) 2022/320. In its opinion of 5 May 2021 Safety and efficacy of a feed additive consisting of expressed mandarin oil from the fruit peels of Citrus reticulata Blanco for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(6):6625. doi: 10.2903/j.efsa.2021.6625). , the Authority could not conclude on the safety of expressed mandarin essential oil as a feed additive for dogs, cats and ornamental fish, because they are not normally exposed to citrus by-products. In its opinion of 29 September 2021, the Authority concluded that ornamental birds are also not normally exposed to citrus by-products. Therefore, an entry covering other animal species except dogs, cats, ornamental fish and ornamental birds should be included in the column species or category of animal of the Annex to Implementing Regulation (EU) 2022/320. The title of Implementing Regulation (EU) 2022/320 should be adjusted accordingly to reflect the fact that the authorisation of expressed mandarin essential oil relates to a broader list of animal species. (5) Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320 should therefore be corrected accordingly. (6) Since safety reasons do not require the immediate application of the corrections, it is appropriate to provide for an extension of the transitional periods laid down in Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320 for the interested parties to prepare themselves to meet the requirements resulting from those corrections. Those Implementing Regulations should therefore be amended accordingly. (7) 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 1

Correction and amendment to Implementing Regulation (EU) 2022/1421

  1. The title of Implementing Regulation (EU) 2022/1421 is replaced by the following: 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.
  2. Article 2 of Implementing Regulation (EU) 2022/1421 is replaced by the following:

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.
  4. The Annex to Implementing Regulation (EU) 2022/1421 is replaced by Annex I to this Regulation.

Article 2

Correction and amendment to Implementing Regulation (EU) 2022/652

  1. Article 2 of Implementing Regulation (EU) 2022/652 is replaced by the following:

Article 2

Transitional measures

  1. The substance specified in the Annex and premixtures containing this substance, 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 substance 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 substance 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.
  4. The Annex to Implementing Regulation (EU) 2022/652 is replaced by Annex II to this Regulation.

Article 3

Correction and amendment to Implementing Regulation (EU) 2022/1490

  1. Article 2 of Implementing Regulation (EU) 2022/1490 is replaced by the following:

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.
  1. 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.
  2. The Annex to Implementing Regulation (EU) 2022/1490 is replaced by Annex III to this Regulation.

Article 4

Correction and amendment to Implementing Regulation (EU) 2022/320

  1. The title of Implementing Regulation (EU) 2022/320 is replaced by the following: Commission Implementing Regulation (EU) 2022/320 of 25 February 2022 concerning the authorisation of expressed mandarin essential oil as a feed additive for certain animal species.
  2. Article 2 of Implementing Regulation (EU) 2022/320 is replaced by the following:

Article 2

Transitional measures

  1. The substance specified in the Annex and premixtures containing this substance, 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 substance 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 substance 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.
  4. The Annex to Implementing Regulation (EU) 2022/320 is replaced by Annex IV to this Regulation.

Article 5

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. Done at Brussels, 15 January 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX I Synonyms: Citrus sinensis (L.) Pers., Citrus aurantium (L.) Dulcis. Natural sources of flavourings – Report No 2 (2007). 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 additiveAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b143-eoExpressed orange essential oil

Additive composition Expressed orange essential oil from fruit peels of Citrus sinensis (L.) Osbeck. 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. 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 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 2032All Suidae species for fattening——172Piglets of all Suidae species——144Sows of all Suidae species——200Ruminants——130Horses——230 Other animal species and categories except dogs, cats, ornamental fish and ornamental birds——50 Natural sources of flavourings – Report No 2 (2007). 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 additiveAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b143-diDistilled 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.

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 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 2032Suidae——200Ruminants——130Horses——225 Other animal species and categories except dogs, cats, ornamental fish and ornamental birds——80 Natural sources of flavourings – Report No 2 (2007). 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 additiveAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b143-fFolded 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. 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 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
  5. The additive shall be incorporated into the feed in the form of a premixture.
  1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
  2. 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.
  3. 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 2032Laying hens and minor poultry species for laying and breeding——23,5Turkeys for fattening——21All Suidae for fattening——34Piglets of all Suidae species——28,5Sows of all Suidae species——41,5Calves (milk replacer)——66,5 Sheep and goats Other ruminants for fattening ——62,5Dairy ruminants other than dairy sheep and dairy goats——40,5Horses——62,5Rabbits——25Fish except ornamental fish——70Other animal species and categories except dogs, cats, ornamental fish and ornamental birds——15,5 Natural sources of flavourings – Report No 2 (2007). 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 additiveAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b143-f-iFolded 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. 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 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
  4. The additive shall be incorporated into the feed in the form of a premixture.
  5. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
  6. 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.
  1. 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 2032Laying hens and minor poultry species for laying and breeding——8Turkeys for fattening——7All Suidae for fattening——11,5Piglets of all Suidae species——9,5Sows of all Suidae species——14Calves (milk replacer)——23 Sheep and goats Other ruminants for fattening ——21,5Dairy ruminants other than dairy sheep and dairy goats——14Horses——21,5Rabbits——8,5Fish except ornamental fish——24,5Other animal species and categories except dogs, cats, ornamental fish and ornamental birds——5,5 Natural sources of flavourings – Report No 2 (2007). 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 additiveAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b143-f-iiFolded 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. 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 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———
  2. The additive shall be incorporated into the feed in the form of a premixture.
  3. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
  4. 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.
  1. 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.
  2. 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

Annex

ANNEX II Natural sources of flavourings – Report No 2 (2007). 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 additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b136-ex—Bitter orange extract Additive composition Bitter orange extract from the fruit of Citrus x aurantium L. Solid form Characterisation of the active substance Bitter orange extract from the fruit of Citrus x aurantium L. as defined by the Council of Europe. Flavonoids: 45-55 % of which Naringin: 20-30 % Neohesperidin: 10-20 % 5-methoxypsoralen (also known as bergapten): ≤ 0,03 % (-)-Synephrine: ≤ 1 % CoE number: 136 Analytical method For the quantification of naringin (phytochemical marker) in the feed additive: High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection All animal species except 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: 102 mg; Laying hens and minor poultry species for laying or breeding: 151 mg; Turkeys for fattening: 136 mg; Piglets of all Suidae species: 182 mg; All Suidae for fattening: 217 mg; Sows of all Suidae species: 268 mg; Dairy ruminants other than dairy sheep and dairy goats: 259 mg; Calves (milk replacer), sheep, goats, other ruminants for fattening, horses, salmonids and all other fin fish: 400 mg; Rabbits: 161 mg; Other animal species and categories except dogs, cats, ornamental fish and ornamental birds: 102 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.
  1. Mixture of bitter orange extract with other botanical additives is permitted provided that the amounts of 5-methoxypsoralen and (-)-synephrine in feed materials and compound feed are lower than the ones resulting from the use of a single additive at the maximum or recommended level for the species or animal category.
  2. The mixture of bitter orange extract from the fruit of Citrus x aurantium L. with other authorised additives obtained from Citrus aurantium L. shall not be allowed in feedingstuffs.
  3. 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. 11 May 2032

Annex

ANNEX III Natural sources of flavourings – Report No 2 (2007). 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 additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b139-eo—Expressed lemon essential oil Additive composition Expressed lemon essential oil from fruit peel of Citrus limon (L.) Osbeck Liquid form Characterisation of the active substance Expressed lemon essential oil obtained by cold expression from fruit peel of Citrus limon (L.) Osbeck as defined by the Council of Europe d-Limonene: 60–73 % β-Pinene (pin-2(10)-ene): 9–18 % γ-Terpinene: 6–12 % α-Pinene (pin-2(3)-ene): 1,3–3,0 % Sabinene (4(10)-thujene): 0,3–3,0 % Geranial: 0,1–2,0 % Neral: 0,1–1,8 % Perillaldehyde: ≤ 0,023 % Furocoumarins: ≤ 0,3 % Methoxycoumarins: ≤ 0,06 % CAS number 84929-31-7 FEMA number 2625 CoE number: 139 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855) Chickens for fattening and minor poultry species for fattening——35

  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 expressed lemon essential oil with other botanical additives is permitted provided that the amounts of perillaldehyde, furocoumarins, and methoxycoumarins 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 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,.

29 September 2032 Turkeys for fattening Salmonids and other fin fish except ornamental fish 40Laying hens and minor poultry species for laying or breeding52All Suidae for fattening74 Piglets of all Suidae species62Sows of all Suidae species92 Calves (milk replacers) Ruminants for fattening other than sheep and goats Dairy ruminants other than sheep and goats 90Horses137Other animal species and categories except dogs, cats, ornamental fish and ornamental birds30 Natural sources of flavourings – Report No 2 (2007). 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 additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b139- rf—Residual fraction of expressed lemon oil distilled Additive composition Residual fraction of expressed lemon oil distilled from fruit peel of Citrus limon (L.) Osbeck Liquid form Characterisation of the active substance Residual fraction of expressed lemon oil distilled obtained by the distillation of lemon essential oil expressed from fruit peel of Citrus limon (L.) Osbeck as defined by the Council of Europe The specifications of the active substance are: d-Limonene: 51–63 % γ-Terpinene: 8–17 % Geranial: 6–12 % Neral:5–9 % β-Pinene (pin-2(10)-ene): 0,3–5,5 % β-Bisabolene: 0,3–4 % Perillaldehyde: ≤ 0,092 % Furocoumarins: ≤ 0,8 % Methoxycoumarins: ≤ 0,22 % CoE number: 139 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855) Chickens for fattening and minor poultry species for fattening——11

  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 residual fraction of expressed lemon oil distilled with other botanical additives is permitted provided that the amounts of perillaldehyde, furocoumarins, and methoxycoumarins 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 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. 29 September 2032

Laying hens and minor poultry species for laying or breeding Turkeys for fattening Rabbits Salmonids and other fin fish except ornamental fish 12Ruminants20 Piglets of all Suidae species20All Suidae for fattening24Sows of all Suidae species30Horses35Other animal species and categories except dogs, cats, ornamental fish and ornamental birds11 Natural sources of flavourings – Report No 2 (2007). 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 additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b139-di—Distilled lemon essential oil (volatile fraction) Additive composition Distilled lemon essential oil (volatile fraction) obtained from lemon essential oil expressed from fruit peel of Citrus limon (L.) Osbeck Liquid form Characterisation of the active substance Distilled lemon essential oil (volatile fraction) obtained by lemon essential oil expressed from fruit peel of Citrus limon (L.) Osbeck as defined by the Council of Europe The specifications of the active substance are: d-Limonene: 66–78 % β-Pinene (pin-2(10)-ene): 5–20 % γ-Terpinene: 1,5–9,5 % α-Pinene (pin-2(3)-ene): 0.5–3,0 % Sabinene: 0,3–3,0 % Furocoumarins: ≤ 0,1 mg/kg Methoxycoumarins: ≤ 0,1 mg/kg CoE number: 139 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855) Chickens for fattening and minor poultry species for fattening——36

  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 distilled lemon essential oil (volatile fraction) with other botanical additives is permitted provided that the amounts of furocoumarins, and methoxycoumarins 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 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. 29 September 2032Laying hens and minor poultry species for laying or breeding53Rabbits56Turkeys for fattening48Piglets of all Suidae species64All Suidae for fattening76Sows of all Suidae species94

Calves (milk replacers) Sheep and goats Other ruminants for fattening 95Horses141Dairy ruminants other than sheep and goats91 Salmonids, ornamental fish and all other fin fish Dogs 60Other animal species and categories30 Natural sources of flavourings – Report No 2 (2007). 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 additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b141-eo—Distilled lime essential oil Additive composition Distilled lime essential oil obtained by unpeeled fruits of the plant species Citrus aurantiifolia (Christm.) Swingle Liquid form Characterisation of the active substance Distilled lime essential oil obtained by steam distillation from unpeeled fruits of the plant species Citrus aurantiifolia (Christm.) Swingle as defined by the Council of Europe The specifications of the active substance are: d-Limonene: 45–52 % γ-Terpinene: 10–14 % Terpinolene: 5,5–10,5 % αΤerpineol: 6–8 % β-Caryophyllene: 0,2–0,8 % Furocoumarins: ≤ 0,0083 % Methoxycoumarins: ≤ 0,03 % CoE number:141 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3519) Chickens for fattening and minor poultry species for fattening——8,5

  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 of distilled lime essential oil with other botanical additives is permitted provided that the amounts of furocoumarins, and methoxycoumarins 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 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. 29 September 2032Laying hens and minor poultry species for laying or breeding12,5Turkeys for fattening11Piglets of all Suidae species15All Suidae for fattening18Lactating sows of all Suidae species22 Sheep and goats Other ruminants for fattening Horses 33,5Calves (milk replacers)35,5Dairy ruminants other than sheep and goats21,5Rabbits13,5Salmonids and other fin fish except ornamental fish30Other animal species and categories except dogs, cats, ornamental fish and ornamental birds8,5

Annex

ANNEX IV Natural sources of flavourings – Report No 2 (2007) 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 additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b142-eo—Expressed mandarin essential oil Additive composition Mandarin essential oil obtained from fruit peel of Citrus reticulata Blanco. Liquid form Characterisation of the active substance Expressed mandarin essential oil obtained by cold expression from fruit peel of Citrus reticulata Blanco as defined by the Council of Europe. d-Limonene: 65–80 % γ-Terpinene: 13-22 % α-Pinene (pin-2(3)-ene): 1-3,5 % Myrcene:1-2 % β-Pinene (pin-2(10)-ene): 1-2 %. Methyl N-methyl anthranilate: 0,15-0,7 % Perillaldehyde: ≤ 0,063 % CAS number: 8008-31-9 FEMA number: 2657 CoE number: 142 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3528) Poultry Rabbits Salmonids ——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 expressed mandarin essential oil with other botanical additives is permitted provided that the amounts of perillaldehyde 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 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. 20 March 2032Suidae——33Ruminants——30Horses——40Other animal species and categories except dogs, cats, ornamental fish and ornamental birds——15

Metadata

Type
Forordning
År
2024
Ikrafttrædelsesdato
1. januar 1970