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)

23.8.2022 EN Official Journal of the European Union L 218/27 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) 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 2003on additives for use in animal nutrition(1), and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2). (2) Expressed orange essential oil, distilled orange essential oil and folded orange oil were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck for all animal species. (4) The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (5) The applicant requested those additives to be authorised also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore, the use of these additives in water for drinking should not be allowed. (6) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 September 2021(3)that, under the proposed conditions of use, expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck do not have adverse effects on animal health, consumer health or the environment. However, no conclusions could be drawn for dogs, cats, ornamental fish and ornamental birds not normally exposed to citrus by-products. The Authority also concluded that expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additives. (1) OJ L 268, 18.10.2003, p. 29. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). (3) EFSA Journal 2021;19(11):6891.L 218/28 EN Official Journal of the European Union 23.8.2022 (7) The Authority also concluded, that expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck are recognised to flavour food and their function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (8) The assessment of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these substances should be authorised as specified in the Annex to this Regulation. (9) Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures. (10) The fact that the additives are not authorised for use as flavourings in water for drinking does not preclude their use in compound feed which is administered via water. (11) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. (12) 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 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 1. The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 12 March 2023in accordance with the rules applicable before 12 September 2022may 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 2023in accordance with the rules applicable before 12 September 2022may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 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.23.8.2022 EN Official Journal of the European Union L 218/29 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 22 August 2022. For the Commission The President Ursula VON DER LEYENANNEX Minimum Maximum content content Identification End of period Composition, chemical formula, Species or category of Maximum number of Additive mg additive/kg of Other provisions of description, analytical method. animal age the additive complete feed with a authorisation moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b143-eo Expressed Additive composition Chickens for - - 80 1. The additive shall be incorporated into the feed 12.9.2032 orange fattening and other in the form of a premixture. essential oil Expressed orange essential oil from minor poultry fruit peels of Citrus sinensis (L.) species for fattening 2. In the directions for use of the additive and Osbeck(1). premixtures, the storage conditions and stabi­ Liquid form Laying hens and lity to heat treatment shall be indicated. other minor Characterisation of the active substance poultry species for 3. Mixture with other botanical additives is per­ laying and breeding mitted provided that the amounts of perillalde­ Essential oil derived by cold purposes hyde added to feedingstuffs by such mixtures is expression from fruit peel of Citrus lower than the one resulting from the use of a sinensis (L.) Osbeck as defined by the Turkeys for single additive at the maximum or recom­ Council of Europe(2). fattening mended level for the species or category of ani­ In the volatile fraction: mal. All Suidae for - - 172 d-Limonene: 93-97 % 4. For users of the additive and premixtures, feed fattening business operators shall establish operational Myrcene: 1,5-3,5 % procedures and organisational measures to ad­ Sabinene: 0,1-1,0 % dress potential risks by inhalation, dermal con­ tact or eyes contact. Where those risks cannot α-Pinene: 0,4-0,8 % Piglets of all Suidae - - 144 be eliminated or reduced to a minimum by such Linalool: 0,1-0,7 % species procedures and measures, the additive and pre­ mixtures shall be used with personal protective Decanal: 0,1-0,7 % equipment, including skin, eye and breathing Octanal: 0,1-0,6 % protection. L 218/30 EN Official Journal of the European Union 23.8.2022Sows - - 200 Perillaldehyde: < 0,05 % CAS number: 8028-48-6 Einecs number: 232-433-8 Ruminants - - 130 FEMA number: 2825 CoE number: 143 Analytical method(3) Horses - - 230 For the determination of d-limonene (phytochemical marker) in the feed additive: Rabbits - - 50 — gas chromatography coupled with flame ionisation detection Fish except (GC-FID) (based on ISO 3140) ornamental fish Other species - - 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en 23.8.2022 EN Official Journal of the European Union L 218/31Minimum Maximum content content Name of the Identification End of period holder of Composition, chemical formula, Species or category of Maximum number of mg additive/kg of Other provisions of authorisation description, analytical method. animal age the additive complete feed with a authorisation Additive moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b143-di Distilled Additive composition Chickens for - - 80 1. The additive shall be incorporated into the feed 12.9.2032 orange fattening and other in the form of a premixture. essential oil Distillate (volatile fraction) of orange minor poultry essential oil, which is obtained from species for fattening fruit peel of Citrus sinensis (L.) Osbeck. 2. In the directions for use of the additive and Laying hens and premixtures, the storage conditions and stabi­ Liquid form other minor lity to heat treatment shall be indicated. poultry species for Characterisation of the active substance laying and breeding purposes 3. Mixture with other botanical additives is per­ Volatile fraction from the distillation mitted provided that the amounts of perillalde­ of orange essential oil expressed (cold Turkeys for hyde added to feedingstuffs by such mixtures is pressed), which is obtained from the fattening lower than the one resulting from the use of a fruit peel of Citrus sinensis (L.) Osbeck single additive at the maximum or recom­ as defined by the Council of Europe(1). mended level for the species or category of ani­ Suidae - - 200 mals. d-Limonene: 93-97,5 % Myrcene: 1,5-3,5 % 4. For users of the additive and premixtures, feed Ruminants - - 130 business operators shall establish operational Sabinene: 0,2-1,0 % procedures and organisational measures to ad­ dress potential risks by inhalation, dermal con­ α-Pinene: 0,3-0,8 % tact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such Linalool: 0,05-0,5 % Horses - - 225 procedures and measures, the additive and pre­ Octanal: 0,05-0,4 % mixtures shall be used with personal protective equipment, including skin, eye and breathing Perillaldehyde: < 0,005 % protection. L 218/32 EN Official Journal of the European Union 23.8.2022Rabbits - - 80 CAS number: 8028-48-6 CoE number: 143 Fish except ornamental fish Analytical method(2) For the determination of d-limonene (phytochemical marker) in the feed Other species - - 80 additive: — gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140) (1) Natural sources of flavourings – Report No 2 (2007). (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en 23.8.2022 EN Official Journal of the European Union L 218/33Minimum Maximum content content Name of the Identification End of period holder of Composition, chemical formula, Species or category of Maximum number of mg additive/kg of Other provisions of authorisation description, analytical method. animal age the additive complete feed with a authorisation Additive moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b143-f Folded orange Additive composition Chickens for - - 15,5 1. The additive shall be incorporated into the feed 12.9.2032 oil fattening and other in the form of a premixture. Folded oil obtained from the fruit peel minor poultry of Citrus sinensis (L.) Osbeck. species for fattening Laying hens and - - 23,5 2. In the directions for use of the additive and Liquid form other minor premixtures, the storage conditions and stabi­ poultry species for lity to heat treatment shall be indicated. Characterisation of the active substance laying and breeding purposes Folded oil produced by the fractional distillation of an expressed orange Turkeys for - - 21 3. Mixture with other botanical additives is per­ essential oil obtained from the fruit fattening mitted provided that the amounts of perillalde­ peel of Citrus sinensis (L.) Osbeck as hyde added to feedingstuffs by such mixtures is defined by the Council of Europe(1). lower than the one resulting from the use of a single additive at the maximum or recom­ All Suidae for - - 34 mended level for the species or category of ani­ fattening Non-volatile fraction: 10,5 % mals. In the volatile fraction: Piglets of all Suidae - - 28,5 species 4. For users of the additive and premixtures, feed business operators shall establish operational d-Limonene: 89-96 % procedures and organisational measures to ad­ dress potential risks by inhalation, dermal con­ Sows - - 41,5 Decanal: 0,5-2 % tact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such Linalool: 0,7-1,7 % procedures and measures, the additive and pre­ Calves (milk - - 66,5 Myrcene: 0,1-1,0 % mixtures shall be used with personal protective replacer) equipment, including skin, eye and breathing Geranial: 0,1-1,0 % protection. L 218/34 EN Official Journal of the European Union 23.8.2022Ruminants for - - 62,5 Perillaldehyde: < 0,3 % fattening CAS number: 8028-48-6 Dairy ruminants - - 40,5 FEMA number: 2822 Analytical method(2) Horses - - 62,5 For the determination of d-limonene (phytochemical marker) in the feed Rabbits - - 25 additive: — gas chromatography coupled with Fish except - - 70 flame ionisation detection ornamental fish (GC-FID) (based on ISO 3140) Other species - - 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en 23.8.2022 EN Official Journal of the European Union L 218/35Minimum Maximum content content Name of the Identification End of period holder of Composition, chemical formula, Species or category of Maximum number of mg additive/kg of Other provisions of authorisation description, analytical method. animal age the additive complete feed with a authorisation Additive moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b143-f-i Folded orange Additive composition Chickens for - - 5,5 1. The additive shall be incorporated into the feed 12.9.2032 oil fattening and other in the form of a premixture. Folded oil obtained from the fruit peel minor poultry of Citrus sinensis (L.) Osbeck. species for fattening 2. In the directions for use of the additive and Liquid form premixtures, the storage conditions and stabi­ Laying hens and - - 8 lity to heat treatment shall be indicated. Characterisation of the active substance other minor poultry species for Folded oil produced by the fractional laying and breeding distillation of an expressed orange purposes 3. Mixture with other botanical additives is per­ essential oil obtained from the fruit mitted provided that the amounts of perillalde­ peel of Citrus sinensis (L.) Osbeck as hyde added to feedingstuffs by such mixtures is defined by the Council of Europe(1). Turkeys for - - 7 lower than the one resulting from the use of a single additive at the maximum or recom­ fattening Non-volatile fraction: 20,9 % mended level for the species or category of ani­ mals. In the volatile fraction: All Suidae for - - 11,5 fattening 4. For users of the additive and premixtures, feed d-Limonene: 79-89 % business operators shall establish operational Decanal: 3,0-5,0 % procedures and organisational measures to ad­ Piglets of all Suidae - - 9,5 dress potential risks by inhalation, dermal con­ Linalool: 2,0-5,0 % species tact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such Myrcene: 0,1-1,0 % procedures and measures, the additive and pre­ Geranial: 0,5-1,8 % Sows - - 14 mixtures shall be used with personal protective equipment, including skin, eye and breathing Perillaldehyde: < 0,6 % protection. L 218/36 EN Official Journal of the European Union 23.8.2022Calves (milk - - 23 CAS number: 8028-48-6 replacer) FEMA number: 2822 Analytical method(2) Ruminants for - - 21,5 fattening For the determination of d-limonene (phytochemical marker) in the feed additive: Dairy ruminants - - 14 — gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140) Horses - - 21,5 Rabbits - - 8,5 Fish except - - 24,5 ornamental fish Other species - - 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en 23.8.2022 EN Official Journal of the European Union L 218/37Minimum Maximum content content Identification End of period Composition, chemical formula, Species or category of Maximum number of Additive mg additive/kg of Other provisions of description, analytical method. animal age the additive complete feed with a authorisation moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b143-f-ii Folded orange Additive composition All animal species - - - 1. The additive shall be incorporated into the feed 12.9.2032 oil in the form of a premixture. Folded oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck. 2. In the directions for use of the additive and premixtures, the storage conditions and stabi­ Liquid form lity to heat treatment shall be indicated. 3. On the label of the additive the following shall Characterisation of the active substance be indicated: ‘Recommended maximum content of the active Folded oil produced by the fractional substance per kg of complete feedingstuff with a distillation of an expressed orange moisture content of 12 %: essential oil which is obtained from — Chickens for fattening and other minor the fruit peel of Citrus sinensis (L.) poultry species for fattening, laying hens Osbeck as defined by the Council of and other minor poultry species for laying Europe(1). and breeding purposes, turkeys for fatten­ ing, Suidae: 50 mg; Non-volatile fraction: 18 % — Calves (milk replacer): 70 mg; — Ruminants except sheep and goats: 60 mg; In the volatile fraction: — Sheep and goats: 70 mg; — Fish, ornamental fish: 2 mg: — Other terrestrial animals: 50 mg’. d-Limonene: 85-95 % 4. The functional group, the identification num­ Linalool: 0,5-4 % ber, the name and the added amount of the active substance shall be indicated on the label CAS number: 8028-48-6 of the premixture where the use level on the label of the premixture would result in exceed­ FEMA number: 2822 ing the level referred to in point 3. L 218/38 EN Official Journal of the European Union 23.8.2022Analytical method(2) 5. For users of the additive and premixtures, feed business operators shall establish operational For the determination of d-limonene procedures and organisational measures to ad­ (phytochemical marker) in the feed dress potential risks by inhalation, dermal con­ additive: tact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such — gas chromatography coupled with procedures and measures, the additive and pre­ flame ionisation detection mixtures shall be used with personal protective (GC-FID) (based on ISO 3140) equipment, including skin, eye and breathing protection. (1) Natural sources of flavourings – Report No 2 (2007). (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en 23.8.2022 EN Official Journal of the European Union L 218/39