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

Official Journal EN of the European Union L series 2024/239 16.1.2024 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 2003on additives for use in animal nutrition(1), 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(2) 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(3), 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(4)for a 10-year period. In its opinion of 23 June 2021(5), 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.

(1) OJ L 268, 18.10.2003, p. 29.

(2) 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).

(3) 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).

(4) 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).

(5) 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).

ELI: http://data.europa.eu/eli/reg_impl/2024/239/oj 1/28EN OJ L, 16.1.2024

(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(6) for a 10-year period. In its opinion of 18 March 2021(7), 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(8) 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(9), 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,

(6) 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).

(7) 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).

(8) 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).

(9) 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).

2/28 ELI: http://data.europa.eu/eli/reg_impl/2024/239/ojEN OJ L, 16.1.2024

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 2024in 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 2025in 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 2026in 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.’

3. 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 2024in 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 2025in 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 2026in 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) 2022/652 is replaced by Annex II to this Regulation.

ELI: http://data.europa.eu/eli/reg_impl/2024/239/oj 3/28EN OJ L, 16.1.2024 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 2024in 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 2025in 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 2026in 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 2024in 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 2025in 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 2026in 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.’

3. The Annex to Implementing Regulation (EU) 2022/320 is replaced by Annex IV to this Regulation.

4/28 ELI: http://data.europa.eu/eli/reg_impl/2024/239/ojEN OJ L, 16.1.2024 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

ELI: http://data.europa.eu/eli/reg_impl/2024/239/oj 5/286/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj ANNEX I Minimum Maximum content content Identification Composition, chemical formula, description, Species or category of Maximum End of period of number of Additive mg active substance/kg Other provisions analytical method. animal age authorisation the additive of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b143-eo Expressed Additive composition orange Chickens for — — 80 1. The additive shall be incorporated 12 September Expressed orange essential oil from fruit essential oil fattening and minor into the feed in the form of a premix­ 2032 peels of Citrus sinensis (L.) Osbeck(1).

poultry species for ture.

Liquid form fattening

2. In the directions for use of the additive Laying hens and and premixtures, the storage condi­ Characterisation of the active substance minor poultry tions and stability to heat treatment Essential oil derived by cold expression species for laying shall be indicated.

from fruit peel of Citrus sinensis (L.) and breeding

3. Mixture with other botanical additives Osbeck as defined by the Council of Turkeys for is permitted provided that the Europe(2). fattening amounts of perillaldehyde added to

In the volatile fraction: feedingstuffs by such mixtures is low­ er than the one resulting from the use d-Limonene: 93-97 % of a single additive at the maximum or All Suidae species — — 172 recommended level for the species or

Myrcene: 1,5-3,5 % for fattening category of animal.

Sabinene: 0,1-1,0 %

4. For users of the additive and premix­ α-Pinene: 0,4-0,8 % tures, feed business operators shall es­ Piglets of all Suidae — — 144 tablish operational procedures and

Linalool: 0,1-0,7 % species organisational measures to address

Decanal: 0,1-0,7 % potential risks by inhalation, dermal contact or eyes contact. Where those

Octanal: 0,1-0,6 % Sows of all Suidae — — 200 risks cannot be eliminated by such

Perillaldehyde: < 0,05 % species procedures and measures, the additive and premixtures shall be used with

CAS number: 8028-48-6 personal skin, eye and breathing pro­ tective equipment.

Einecs number: 232-433-8 Ruminants — — 130

FEMA number: 2825

CoE number: 143 Horses — — 230 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 7/28 Analytical method(3) Other animal — — 50 species and For the determination of d-limonene categories except (phytochemical marker) in the feed dogs, cats,

additive: ornamental fish — gas chromatography coupled with and ornamental flame ionisation detection (GC-FID) birds (based on ISO 3140)

(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 OJ L,

16.1.2024 EN8/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj Minimum Maximum content content Identification Composition, chemical formula, description, Species or category of Maximum End of period of number of Additive mg active substance/kg Other provisions analytical method. animal age authorisation the additive of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b143-di Distilled orange Additive composition Chickens for — — 80 1. The additive shall be incorporated 12 September essential oil Distillate (volatile fraction) of orange fattening and minor into the feed in the form of a premix­ 2032 essential oil, which is obtained from fruit poultry species for ture.

peel of Citrus sinensis (L.) Osbeck. fattening

2. In the directions for use of the additive Liquid form Laying hens and and premixtures, the storage condi­ minor poultry tions and stability to heat treatment Characterisation of the active substance species for laying shall be indicated.

and breeding Volatile fraction from the distillation of 3. Mixture with other botanical additives orange essential oil expressed (cold Turkeys for is permitted provided that the pressed), which is obtained from the fruit fattening amounts of perillaldehyde added to peel of Citrus sinensis (L.) Osbeck as defined feedingstuffs by such mixtures is low­ by the Council of Europe(1). er than the one resulting from the use Suidae — — 200 of a single additive at the maximum or d-Limonene: 93-97,5 % recommended level for the species or

Myrcene: 1,5-3,5 % category of animals.

Ruminants — — 130

Sabinene: 0,2-1,0 % α-Pinene: 0,3-0,8 % Horses — — 225 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 9/28 Other animal — — 80

Linalool: 0,05-0,5 % species and 4. For users of the additive and premix­

Octanal: 0,05-0,4 % categories except tures, feed business operators shall es­ dogs, cats, tablish operational procedures and

Perillaldehyde: < 0,005 % ornamental fish organisational measures to address and ornamental potential risks by inhalation, dermal

CAS number: 8028-48-6 birds contact or eyes contact. Where those

CoE number: 143 risks cannot be eliminated by such procedures and measures, the additive Analytical method(2) and premixtures shall be used with personal skin, eye and breathing pro­ For the determination of d-limonene tective equipment.

(phytochemical marker) in the feed

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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports OJ L,

16.1.2024 EN10/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj Minimum Maximum content content Identification Composition, chemical formula, description, Species or category of Maximum End of period of number of Additive mg active substance/kg Other provisions analytical method. animal age authorisation the additive of complete feed with a 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 12 September oil Folded oil obtained from the fruit peel of fattening and minor into the feed in the form of a premix­ 2032 Citrus sinensis (L.) Osbeck. poultry species for ture.

fattening Liquid form 2. In the directions for use of the additive and premixtures, the storage condi­ Characterisation of the active substance Laying hens and — — 23,5 tions and stability to heat treatment minor poultry shall be indicated.

Folded oil produced by the fractional species for laying distillation of an expressed orange 3. Mixture with other botanical additives and breeding essential oil obtained from the fruit peel is permitted provided that the of Citrus sinensis (L.) Osbeck as defined by amounts of perillaldehyde added to the Council of Europe(1). Turkeys for — — 21 feedingstuffs by such mixtures is low­ er than the one resulting from the use fattening Non-volatile fraction: 10,5 % of a single additive at the maximum or

In the volatile fraction: recommended level for the species or All Suidae for — — 34 category of animals. d-Limonene: 89-96 % fattening

Decanal: 0,5-2 %

Linalool: 0,7-1,7 % Piglets of all Suidae — — 28,5 species

Myrcene: 0,1-1,0 %

Geranial: 0,1-1,0 % Sows of all Suidae — — 41,5

Perillaldehyde: < 0,3 % species

CAS number: 8028-48-6 Calves (milk — — 66,5

FEMA number: 2822 replacer) EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 11/28 Analytical method(2) Sheep and goats — — 62,5 4. For users of the additive and premix­ For the determination of d-limonene Other ruminants tures, feed business operators shall es­ (phytochemical marker) in the feed for fattening tablish operational procedures and

additive: organisational measures to address potential risks by inhalation, dermal — gas chromatography coupled with Dairy ruminants — — 40,5 contact or eyes contact. Where those flame ionisation detection (GC-FID) other than dairy risks cannot be eliminated by such (based on ISO 3140) sheep and dairy procedures and measures, the additive goats and premixtures shall be used with personal skin, eye and breathing pro­ tective equipment.

Horses — — 62,5 Rabbits — — 25 Fish except — — 70 ornamental fish Other animal — — 15,5 species and categories except dogs, cats, ornamental fish and ornamental birds

(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 OJ L,

16.1.2024 EN12/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj Minimum Maximum content content Identification Composition, chemical formula, description, Species or category of Maximum End of period of number of Additive mg active substance/kg Other provisions analytical method. animal age authorisation the additive of complete feed with a 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 12 September oil Folded oil obtained from the fruit peel of fattening and minor into the feed in the form of a premix­ 2032 Citrus sinensis (L.) Osbeck. poultry species for ture.

fattening 2. In the directions for use of the additive Liquid form and premixtures, the storage condi­ tions and stability to heat treatment Characterisation of the active substance Laying hens and — — 8 shall be indicated.

minor poultry Folded oil produced by the fractional species for laying 3. Mixture with other botanical additives distillation of an expressed orange and breeding is permitted provided that the essential oil obtained from the fruit peel amounts of perillaldehyde added to of Citrus sinensis (L.) Osbeck as defined by feedingstuffs by such mixtures is low­ the Council of Europe(1). Turkeys for — — 7 er than the one resulting from the use Non-volatile fraction: 20,9 % fattening of a single additive at the maximum or recommended level for the species or

In the volatile fraction: category of animals.

All Suidae for — — 11,5 d-Limonene: 79-89 % fattening

Decanal: 3,0-5,0 %

Linalool: 2,0-5,0 % Piglets of all Suidae — — 9,5 species

Myrcene: 0,1-1,0 %

Geranial: 0,5-1,8 % Sows of all Suidae — — 14

Perillaldehyde: < 0,6 % species

CAS number: 8028-48-6 Calves (milk — — 23

FEMA number: 2822 replacer) EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 13/28 Analytical method(2) Sheep and goats — — 21,5 4. For users of the additive and premix­ For the determination of d-limonene Other ruminants tures, feed business operators shall es­ (phytochemical marker) in the feed for fattening tablish operational procedures and

additive: organisational measures to address potential risks by inhalation, dermal — gas chromatography coupled with Dairy ruminants — — 14 contact or eyes contact. Where those flame ionisation detection (GC-FID) other than dairy risks cannot be eliminated by such (based on ISO 11024) sheep and dairy procedures and measures, the additive goats and premixtures shall be used with personal skin, eye and breathing pro­ tective equipment.

Horses — — 21,5 Rabbits — — 8,5 Fish except — — 24,5 ornamental fish Other animal — — 5,5 species and categories except dogs, cats, ornamental fish and ornamental birds

(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 OJ L,

16.1.2024 EN14/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj Minimum Maximum content content Identification Composition, chemical formula, description, Species or category of Maximum End of period of number of Additive mg active substance/kg Other provisions analytical method. animal age authorisation the additive of complete feed with a 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 12 September oil except horses, into the feed in the form of a premix­ 2032 Folded oil obtained from the fruit peel of rabbits, dogs, cats, ture.

Citrus sinensis (L.) Osbeck. ornamental fish

2. In the directions for use of the additive Liquid form and ornamental and premixtures, the storage condi­ birds tions and stability to heat treatment Characterisation of the active substance shall be indicated.

Folded oil produced by the fractional

3. On the label of the additive the follow­ distillation of an expressed orange

ing shall be indicated: essential oil which is obtained from the fruit peel of Citrus sinensis (L.) Osbeck as ‘Recommended maximum content of defined by the Council of Europe(1). the active substance per kg of com­ plete feedingstuff with a moisture Non-volatile fraction: 18 % content of 12 %:

In the volatile fraction: — Chickens for fattening and minor d-Limonene: 85-95 % poultry species for fattening, lay­ ing hens and minor poultry spe­

Linalool: 0,5-4 % cies for laying and breeding, tur­ keys for fattening, Suidae: 50 mg;

CAS number: 8028-48-6 — Calves (milk replacer), sheep,

FEMA number: 2822 goats: 70 mg;

EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 15/28 Analytical method(2) — Ruminants except sheep and

goats: 60 mg; For the determination of d-limonene (phytochemical marker) in the feed — Other animal species and cate­

additive: gories except horses, rabbits, dogs, cats, ornamental fish and — gas chromatography coupled with

ornamental birds: 2 mg’. flame ionisation detection (GC-FID) (based on ISO 3140) 4. The functional group, the identifica­ tion number, the name and the added amount of the active substance shall be indicated on the label of the pre­ mixture 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 premix­ tures, feed business operators shall es­ tablish 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 pro­ tective equipment.

(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 OJ L,

16.1.2024 EN16/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj ANNEX II Minimum Maximum Name of content content Identification the holder Species or Composition, chemical formula, description, Maximum End of period of number of of Additive analytical method. category of age mg active substance/kg Other provisions authorisation the additive authorisa- animal of complete feed with a tion moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b136-ex — Bitter Additive composition All animal — — 1. The additive shall be incorporated into the 11 May 2032 orange species feed in the form of a premixture.

Bitter orange extract from the fruit of extract except dogs, Citrus x aurantium L. 2. In the directions for use of the additive and cats, premixtures, the storage conditions and Solid form ornamental stability to heat treatment shall be indi­ fish and cated.

Characterisation of the active substance ornamental birds 3. On the label of the additive the following Bitter orange extract from the fruit of

shall be indicated:

Citrus x aurantium L. as defined by the Council of Europe(1). ‘Recommended maximum content of the active substance per kg of complete fee­

Flavonoids: 45-55 % of which dingstuff with a moisture content of 12 %: — Naringin: 20-30 % — Chickens for fattening and minor — Neohesperidin: 10-20 %

poultry species for fattening: 102 mg;

5-methoxypsoralen (also known as — Laying hens and minor poultry spe­ bergapten): ≤ 0,03 %

cies for laying or breeding: 151 mg; (-)-Synephrine: ≤ 1 % — Turkeys for fattening: 136 mg;

CoE number: 136 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 17/28 Analytical method(2) — Piglets of all Suidae species: 182 mg;

For the quantification of naringin — All Suidae for fattening: 217 mg; (phytochemical marker) in the feed — Sows of all Suidae species: 268 mg;

additive: — Dairy ruminants other than dairy — High performance liquid chromato­

sheep and dairy goats: 259 mg; graphy (HPLC) with spectrophoto­ metric (UV) detection — 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 re­ ferred to in point 3.

OJ L,

16.1.2024 EN18/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj

5. 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.

6. 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 fee­ dingstuffs.

7. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and organisational measures to address potential risks by in­ halation, dermal contact or eyes contact.

Where those risks cannot be eliminated by such procedures and measures, the ad­ ditive and premixtures shall be used with personal skin, eye and breathing protec­ tive equipment.

(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 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 19/28 ANNEX III Minimum Maximum Name of Identifica- content content the Species or tion number Composition, chemical formula, description, Maximum End of period of holder of Additive category of Other provisions of the analytical method age mg active substance/kg authorisation authori- animal additive of complete feed with a sation moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b139-eo — Expressed Additive composition lemon Chickens for — — 35 1. The additive shall be incorpo­ 29 September 2032 Expressed lemon essential oil from fruit essential oil fattening and rated into the feed in the form peel of Citrus limon (L.) Osbeck minor poultry of a premixture.

Liquid form species for

2. In the directions for use of the fattening additive and premixtures, the Characterisation of the active substance storage conditions and stabi­ Expressed lemon essential oil obtained by lity to heat treatment shall be cold expression from fruit peel of Citrus Turkeys for 40 indicated.

limon (L.) Osbeck as defined by the Council fattening

3. Mixture of expressed lemon of Europe(1) Salmonids and essential oil with other bota­ d-Limonene: 60–73 % other fin fish nical additives is permitted except provided that the amounts β-Pinene (pin-2(10)-ene): 9–18 % ornamental fish of perillaldehyde, furocou­ marins, and methoxycou­ γ-Terpinene: 6–12 % marins in feed materials and α-Pinene (pin-2(3)-ene): 1,3–3,0 % compound feed are lower Laying hens and 52 than the one resulting from Sabinene (4(10)-thujene): 0,3–3,0 % minor poultry the use of a single additive at species for

Geranial: 0,1–2,0 % the maximum or recom­ laying or mended level for the species

Neral: 0,1–1,8 % breeding or animal category.

Perillaldehyde: ≤ 0,023 %

Furocoumarins: ≤ 0,3 % All Suidae for 74

Methoxycoumarins: ≤ 0,06 % fattening OJ L,

16.1.2024 EN20/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj CAS number 84929-31-7 Piglets of all 62 Suidae species 4. For users of the additive and FEMA number 2625 premixtures, feed business

CoE number: 139 operators shall establish op­ Sows of all 92 erational procedures and or­ Suidae species Analytical method(2) ganisational measures to ad­ dress potential risks by For the quantification of phytochemical Calves (milk 90 inhalation, dermal contact marker d-limonene in the feed additive: replacers) or eyes contact. Where those risks cannot be eliminated by — Gas chromatography coupled with Ruminants for such procedures and mea­ flame ionisation detection (GC-FID) fattening other sures, the additive and pre­ (based on ISO 855) than sheep and mixtures shall be used with goats personal skin, eye and breath­ Dairy ing protective equipment,.

ruminants other than sheep and goats Horses 137 Other animal 30 species and categories except dogs, cats, ornamental fish and ornamental birds

(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 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 21/28 Minimum Maximum Identifica- Name of content content the Species or tion number Composition, chemical formula, description, Maximum End of period of holder of Additive category of Other provisions of the authori- analytical method animal age mg active substance/kg authorisation additive sation of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b139- rf — Residual Additive composition Chickens for — — 11 1. The additive shall be incorpo­ 29 September 2032 fraction of fattening and rated into the feed in the form Residual fraction of expressed lemon oil expressed minor poultry of a premixture.

distilled from fruit peel of Citrus limon (L.) lemon oil species for Osbeck 2. In the directions for use of the distilled fattening additive and premixtures, the Liquid form storage conditions and stabi­ Laying hens and 12 lity to heat treatment shall be Characterisation of the active substance minor poultry indicated.

species for Residual fraction of expressed lemon oil laying or 3. Mixture of residual fraction of distilled obtained by the distillation of breeding expressed lemon oil distilled lemon essential oil expressed from fruit with other botanical additives peel of Citrus limon (L.) Osbeck as defined Turkeys for is permitted provided that the by the Council of Europe(1) fattening amounts of perillaldehyde, Rabbits furocoumarins, and methox­ ycoumarins in feed materials Salmonids and and compound feed are lower other fin fish than the one resulting from except the use of a single additive at ornamental fish the maximum or recom­ mended level for the species Ruminants 20 or animal category.

OJ L,

16.1.2024 EN22/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj Piglets of all 20 The specifications of the active substance 4. For users of the additive and Suidae species

are: premixtures, feed business d-Limonene: 51–63 % operators shall establish op­ All Suidae for 24 erational procedures and or­ γ-Terpinene: 8–17 % fattening ganisational measures to ad­

Geranial: 6–12 % dress potential risks by inhalation, dermal contact

Neral:5–9 % Sows of all 30 or eyes contact. Where those Suidae species β-Pinene (pin-2(10)-ene): 0,3–5,5 % risks cannot be eliminated by such procedures and mea­ β-Bisabolene: 0,3–4 % Horses 35 sures, the additive and pre­

Perillaldehyde: ≤ 0,092 % mixtures shall be used with Other animal 11 personal skin, eye and breath­

Furocoumarins: ≤ 0,8 % species and ing protective equipment.

Methoxycoumarins: ≤ 0,22 % categories except dogs,

CoE number: 139 cats, ornamental fish Analytical method(2) and ornamental birds 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)

(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 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 23/28 Minimum Maximum Name of Identifica- content content the Species or tion number Composition, chemical formula, description, Maximum End of period of holder of Additive category of Other provisions of the analytical method age mg active substance/kg authorisation authori- animal additive of complete feed with a sation moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b139-di — Distilled Additive composition Chickens for — — 36 1. The additive shall be incorpo­ 29 September 2032 lemon Distilled lemon essential oil (volatile fattening and rated into the feed in the form essential oil fraction) obtained from lemon essential oil minor poultry of a premixture.

(volatile expressed from fruit peel of Citrus limon species for fraction) 2. In the directions for use of the (L.) Osbeck fattening additive and premixtures, the storage conditions and stabi­ Liquid form lity to heat treatment shall be Laying hens and 53 indicated.

Characterisation of the active substance minor poultry species for 3. Mixture of distilled lemon es­ Distilled lemon essential oil (volatile laying or sential oil (volatile fraction) fraction) obtained by lemon essential oil breeding with other botanical additives expressed from fruit peel of Citrus limon is permitted provided that the (L.) Osbeck as defined by the Council of amounts of furocoumarins, Europe(1) and methoxycoumarins in Rabbits 56 The specifications of the active substance feed materials and compound

are: feed are lower than the one resulting from the use of a d-Limonene: 66–78 % Turkeys for 48 single additive at the maxi­ fattening β-Pinene (pin-2(10)-ene): 5–20 % mum or recommended level for the species or animal ca­ γ-Terpinene: 1,5–9,5 % tegory.

Piglets of all 64 α-Pinene (pin-2(3)-ene): 0.5–3,0 % Suidae species

Sabinene: 0,3–3,0 %

Furocoumarins: ≤ 0,1 mg/kg

Methoxycoumarins: ≤ 0,1 mg/kg All Suidae for 76 fattening Sows of all 94 Suidae species OJ L,

16.1.2024 EN24/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj

CoE number: 139 Calves (milk 95 replacers) 4. For users of the additive and premixtures, feed business Analytical method(2) Sheep and goats operators shall establish op­ For the quantification of phytochemical Other erational procedures and or­ marker d-limonene in the feed additive: ruminants for ganisational measures to ad­ fattening dress potential risks by — Gas chromatography coupled with inhalation, dermal contact flame ionisation detection (GC-FID) or eyes contact. Where those (based on ISO 855) Horses 141 risks cannot be eliminated by such procedures and mea­ Dairy 91 sures, the additive and pre­ ruminants mixtures shall be used with other than personal skin, eye and breath­ sheep and goats ing protective equipment.

Salmonids, 60 ornamental fish and all other fin fish Dogs Other animal 30 species and categories

(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 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 25/28 Minimum Maximum Identifica- Name of content content the Species or tion number Composition, chemical formula, description, Maximum End of period of holder of Additive category of Other provisions of the authori- analytical method animal age mg active substance/kg authorisation additive of complete feed with a sation moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b141-eo — Distilled lime Additive composition Chickens for — — 8,5 1. The additive shall be incorpo­ 29 September 2032 essential oil Distilled lime essential oil obtained by fattening and rated into the feed in the form unpeeled fruits of the plant species Citrus minor poultry of a premixture.

aurantiifolia (Christm.) Swingle species for

2. In the directions for use of the fattening Liquid form additive and premixtures, the storage conditions and stabi­ Characterisation of the active substance lity to heat treatment shall be Laying hens and 12,5 indicated.

Distilled lime essential oil obtained by minor poultry steam distillation from unpeeled fruits of species for 3. Mixture of distilled lime es­ the plant species Citrus aurantiifolia laying or sential oil with other botani­ (Christm.) Swingle as defined by the breeding cal additives is permitted pro­ Council of Europe(1) vided that the amounts of furocoumarins, and methox­ The specifications of the active substance ycoumarins in feed materials

are: Turkeys for 11 and compound feed are lower fattening d-Limonene: 45–52 % than the one resulting from the use of a single additive at γ-Terpinene: 10–14 % the maximum or recom­ Piglets of all 15

Terpinolene: 5,5–10,5 % mended level for the species Suidae species or animal category. αΤerpineol: 6–8 % β-Caryophyllene: 0,2–0,8 % All Suidae for 18

Furocoumarins: ≤ 0,0083 % fattening

Methoxycoumarins: ≤ 0,03 % Lactating sows 22 of all Suidae species OJ L,

16.1.2024 EN26/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj Sheep and goats 33,5

CoE number:141

4. For users of the additive and Other premixtures, feed business Analytical method(2) ruminants for operators shall establish op­ fattening For the quantification of phytochemical erational procedures and or­ marker d-limonene in the feed additive: Horses ganisational measures to ad­ dress potential risks by — Gas chromatography coupled with inhalation, dermal contact flame ionisation detection (GC-FID) Calves (milk 35,5 or eyes contact. Where those (based on ISO 3519) replacers) risks cannot be eliminated by such procedures and mea­ Dairy 21,5 sures, the additive and pre­ ruminants mixtures shall be used with other than personal skin, eye and breath­ sheep and goats ing protective equipment.

Rabbits 13,5 Salmonids and 30 other fin fish except ornamental fish Other animal 8,5 species and categories except dogs, cats, ornamental fish and ornamental birds

(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 EN OJ L,

16.1.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj 27/28 ANNEX IV Minimum Maximum Name of content content Identifica- the Species or tion number Composition, chemical formula, description, Maximum End of period of holder of Additive category of Other provisions of the analytical method. age authorisation authori- animal mg active substance/kg additive sation of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b142-eo — Expressed Additive composition Poultry — — 15 1. The additive shall be incorpo­ 20 March 2032 mandarin rated into the feed in the form Mandarin essential oil obtained from fruit Rabbits essential oil of a premixture.

peel of Citrus reticulata Blanco.

Salmonids

2. In the directions for use of the Liquid form additive and premixtures, the Suidae — — 33 storage conditions and stabi­ Characterisation of the active substance lity to heat treatment shall be Expressed mandarin essential oil obtained indicated.

by cold expression from fruit peel of Citrus Ruminants — — 30

3. Mixture of expressed man­ reticulata Blanco as defined by the Council darin essential oil with other of Europe(1).

Horses — — 40 botanical additives is per­ d-Limonene: 65–80 % mitted provided that the amounts of perillaldehyde in γ-Terpinene: 13-22 % Other animal — — 15 feed materials and compound α-Pinene (pin-2(3)-ene): species and feed are lower than the one categories resulting from the use of a 1-3,5 % except dogs, single additive at the maxi­

Myrcene:1-2 % cats, mum or recommended level ornamental fish for the species or animal ca­ β-Pinene (pin-2(10)-ene): and ornamental tegory. birds 1-2 %.

Methyl N-methyl anthranilate: 0,15-0,7 %

Perillaldehyde: ≤ 0,063 % OJ L,

16.1.2024 EN28/28

ELI:

http://data.europa.eu/eli/reg_impl/2024/239/oj

CAS number: 8008-31-9 4. For users of the additive and premixtures, feed business

FEMA number: 2657 operators shall establish op­

CoE number: 142 erational procedures and or­ ganisational measures to ad­ Analytical method(2) dress potential risks by inhalation, dermal contact For the quantification of phytochemical or eyes contact. Where those marker d-limonene in the feed additive:

risks cannot be eliminated by — Gas chromatography coupled with such procedures and mea­ flame ionisation detection (GC-FID) sures, the additive and pre­ (based on ISO 3528) mixtures shall be used with personal skin, eye and breath­ ing protective equipment.

(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 EN OJ L,

16.1.2024