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Document 32024R0239
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
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
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
C/2024/59
OJ L, 2024/239, 16.1.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/239/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
Official Journal |
EN Series L |
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 2003 on 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. |
(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, |
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.’
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 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.’
2. 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.
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.’
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.’
3. 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
(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).
(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).
ANNEX I
Identification number of the additive |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
||||||||||||||||||
2b143-eo |
Expressed orange essential oil |
Additive composition Expressed orange essential oil from fruit peels of Citrus sinensis (L.) Osbeck (1). Liquid form Characterisation of the active substance Essential oil derived by cold expression from fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (2). In the volatile fraction: d-Limonene: 93-97 % Myrcene: 1,5-3,5 % Sabinene: 0,1-1,0 % α-Pinene: 0,4-0,8 % Linalool: 0,1-0,7 % Decanal: 0,1-0,7 % Octanal: 0,1-0,6 % Perillaldehyde: < 0,05 % CAS number: 8028-48-6 Einecs number: 232-433-8 FEMA number: 2825 CoE number: 143 Analytical method (3) For the determination of d-limonene (phytochemical marker) in the feed additive:
|
Chickens for fattening and minor poultry species for fattening Laying hens and minor poultry species for laying and breeding Turkeys for fattening |
— |
— |
80 |
|
12 September 2032 |
||||||||||
All Suidae species for fattening |
— |
— |
172 |
|||||||||||||||
Piglets of all Suidae species |
— |
— |
144 |
|||||||||||||||
Sows of all Suidae species |
— |
— |
200 |
|||||||||||||||
Ruminants |
— |
— |
130 |
|||||||||||||||
Horses |
— |
— |
230 |
|||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
— |
— |
50 |
Identification number of the additive |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
||||||||||||||||||
2b143-di |
Distilled orange essential oil |
Additive composition Distillate (volatile fraction) of orange essential oil, which is obtained from fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Volatile fraction from the distillation of orange essential oil expressed (cold pressed), which is obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (4). d-Limonene: 93-97,5 % Myrcene: 1,5-3,5 % Sabinene: 0,2-1,0 % α-Pinene: 0,3-0,8 % Linalool: 0,05-0,5 % Octanal: 0,05-0,4 % Perillaldehyde: < 0,005 % CAS number: 8028-48-6 CoE number: 143 Analytical method (5) For the determination of d-limonene (phytochemical marker) in the feed additive:
|
Chickens for fattening and minor poultry species for fattening Laying hens and minor poultry species for laying and breeding Turkeys for fattening |
— |
— |
80 |
|
12 September 2032 |
||||||||||
Suidae |
— |
— |
200 |
|||||||||||||||
Ruminants |
— |
— |
130 |
|||||||||||||||
Horses |
— |
— |
225 |
|||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
— |
— |
80 |
Identification number of the additive |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
||||||||||||||||||
2b143-f |
Folded orange oil |
Additive composition Folded oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Folded oil produced by the fractional distillation of an expressed orange essential oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (6). Non-volatile fraction: 10,5 % In the volatile fraction: d-Limonene: 89-96 % Decanal: 0,5-2 % Linalool: 0,7-1,7 % Myrcene: 0,1-1,0 % Geranial: 0,1-1,0 % Perillaldehyde: < 0,3 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method (7) For the determination of d-limonene (phytochemical marker) in the feed additive:
|
Chickens for fattening and minor poultry species for fattening |
— |
— |
15,5 |
|
12 September 2032 |
||||||||||
Laying hens and minor poultry species for laying and breeding |
— |
— |
23,5 |
|||||||||||||||
Turkeys for fattening |
— |
— |
21 |
|||||||||||||||
All Suidae for fattening |
— |
— |
34 |
|||||||||||||||
Piglets of all Suidae species |
— |
— |
28,5 |
|||||||||||||||
Sows of all Suidae species |
— |
— |
41,5 |
|||||||||||||||
Calves (milk replacer) |
— |
— |
66,5 |
|||||||||||||||
Sheep and goats Other ruminants for fattening |
— |
— |
62,5 |
|||||||||||||||
Dairy ruminants other than dairy sheep and dairy goats |
— |
— |
40,5 |
|||||||||||||||
Horses |
— |
— |
62,5 |
|||||||||||||||
Rabbits |
— |
— |
25 |
|||||||||||||||
Fish except ornamental fish |
— |
— |
70 |
|||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
— |
— |
15,5 |
Identification number of the additive |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
||||||||||||||||||
2b143-f-i |
Folded orange oil |
Additive composition Folded oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Folded oil produced by the fractional distillation of an expressed orange essential oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (8). Non-volatile fraction: 20,9 % In the volatile fraction: d-Limonene: 79-89 % Decanal: 3,0-5,0 % Linalool: 2,0-5,0 % Myrcene: 0,1-1,0 % Geranial: 0,5-1,8 % Perillaldehyde: < 0,6 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method (9) For the determination of d-limonene (phytochemical marker) in the feed additive:
|
Chickens for fattening and minor poultry species for fattening |
— |
— |
5,5 |
|
12 September 2032 |
||||||||||
Laying hens and minor poultry species for laying and breeding |
— |
— |
8 |
|||||||||||||||
Turkeys for fattening |
— |
— |
7 |
|||||||||||||||
All Suidae for fattening |
— |
— |
11,5 |
|||||||||||||||
Piglets of all Suidae species |
— |
— |
9,5 |
|||||||||||||||
Sows of all Suidae species |
— |
— |
14 |
|||||||||||||||
Calves (milk replacer) |
— |
— |
23 |
|||||||||||||||
Sheep and goats Other ruminants for fattening |
— |
— |
21,5 |
|||||||||||||||
Dairy ruminants other than dairy sheep and dairy goats |
— |
— |
14 |
|||||||||||||||
Horses |
— |
— |
21,5 |
|||||||||||||||
Rabbits |
— |
— |
8,5 |
|||||||||||||||
Fish except ornamental fish |
— |
— |
24,5 |
|||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
— |
— |
5,5 |
Identification number of the additive |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
||||||||||||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
||||||||||||||||||||||||||||
2b143-f-ii |
Folded orange oil |
Additive composition Folded oil obtained from the fruit peel of Citrus sinensis (L.) Osbeck. Liquid form Characterisation of the active substance Folded oil produced by the fractional distillation of an expressed orange essential oil which is obtained from the fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe (10). Non-volatile fraction: 18 % In the volatile fraction: d-Limonene: 85-95 % Linalool: 0,5-4 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method (11) For the determination of d-limonene (phytochemical marker) in the feed additive:
|
All animal species except horses, rabbits, dogs, cats, ornamental fish and ornamental birds |
— |
— |
— |
|
12 September 2032 |
(1) Synonyms: Citrus sinensis (L.) Pers., Citrus aurantium (L.) Dulcis.
(2) Natural sources of flavourings – Report No 2 (2007).
(3) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
(4) Natural sources of flavourings – Report No 2 (2007).
(5) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
(6) Natural sources of flavourings – Report No 2 (2007).
(7) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
(8) Natural sources of flavourings – Report No 2 (2007).
(9) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
(10) Natural sources of flavourings – Report No 2 (2007).
(11) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
ANNEX II
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||||||||||||||||||||||||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||||||||||||||||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
|||||||||||||||||||||||||||||||||||||||||||||||||
2b136-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 (1). Flavonoids: 45-55 % of which
5-methoxypsoralen (also known as bergapten): ≤ 0,03 % (-)-Synephrine: ≤ 1 % CoE number: 136 Analytical method (2) For the quantification of naringin (phytochemical marker) in the feed additive:
|
All animal species except dogs, cats, ornamental fish and ornamental birds |
— |
— |
|
|
11 May 2032 |
(1) Natural sources of flavourings – Report No 2 (2007).
(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
ANNEX III
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
|||||||||||||||||||
2b139-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 (1) 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 (2) For the quantification of phytochemical marker d-limonene in the feed additive:
|
Chickens for fattening and minor poultry species for fattening |
— |
— |
35 |
|
29 September 2032 |
||||||||||
Turkeys for fattening Salmonids and other fin fish except ornamental fish |
40 |
||||||||||||||||||
Laying hens and minor poultry species for laying or breeding |
52 |
||||||||||||||||||
All Suidae for fattening |
74 |
||||||||||||||||||
Piglets of all Suidae species |
62 |
||||||||||||||||||
Sows of all Suidae species |
92 |
||||||||||||||||||
Calves (milk replacers) Ruminants for fattening other than sheep and goats Dairy ruminants other than sheep and goats |
90 |
||||||||||||||||||
Horses |
137 |
||||||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
30 |
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
|||||||||||||||||||
2b139- 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 (3) 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 (4) For the quantification of phytochemical marker d-limonene in the feed additive:
|
Chickens for fattening and minor poultry species for fattening |
— |
— |
11 |
|
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 |
12 |
||||||||||||||||||
Ruminants |
20 |
||||||||||||||||||
Piglets of all Suidae species |
20 |
||||||||||||||||||
All Suidae for fattening |
24 |
||||||||||||||||||
Sows of all Suidae species |
30 |
||||||||||||||||||
Horses |
35 |
||||||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
11 |
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
|||||||||||||||||||
2b139-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 (5) 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 (6) For the quantification of phytochemical marker d-limonene in the feed additive:
|
Chickens for fattening and minor poultry species for fattening |
— |
— |
36 |
|
29 September 2032 |
||||||||||
Laying hens and minor poultry species for laying or breeding |
53 |
||||||||||||||||||
Rabbits |
56 |
||||||||||||||||||
Turkeys for fattening |
48 |
||||||||||||||||||
Piglets of all Suidae species |
64 |
||||||||||||||||||
All Suidae for fattening |
76 |
||||||||||||||||||
Sows of all Suidae species |
94 |
||||||||||||||||||
Calves (milk replacers) Sheep and goats Other ruminants for fattening |
95 |
||||||||||||||||||
Horses |
141 |
||||||||||||||||||
Dairy ruminants other than sheep and goats |
91 |
||||||||||||||||||
Salmonids, ornamental fish and all other fin fish Dogs |
60 |
||||||||||||||||||
Other animal species and categories |
30 |
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
|||||||||||||||||||
2b141-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 (7) 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 (8) For the quantification of phytochemical marker d-limonene in the feed additive:
|
Chickens for fattening and minor poultry species for fattening |
— |
— |
8,5 |
|
29 September 2032 |
||||||||||
Laying hens and minor poultry species for laying or breeding |
12,5 |
||||||||||||||||||
Turkeys for fattening |
11 |
||||||||||||||||||
Piglets of all Suidae species |
15 |
||||||||||||||||||
All Suidae for fattening |
18 |
||||||||||||||||||
Lactating sows of all Suidae species |
22 |
||||||||||||||||||
Sheep and goats Other ruminants for fattening Horses |
33,5 |
||||||||||||||||||
Calves (milk replacers) |
35,5 |
||||||||||||||||||
Dairy ruminants other than sheep and goats |
21,5 |
||||||||||||||||||
Rabbits |
13,5 |
||||||||||||||||||
Salmonids and other fin fish except ornamental fish |
30 |
||||||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
8,5 |
(1) Natural sources of flavourings – Report No 2 (2007).
(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
(3) Natural sources of flavourings – Report No 2 (2007).
(4) 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
(5) Natural sources of flavourings – Report No 2 (2007).
(6) 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
(7) Natural sources of flavourings – Report No 2 (2007).
(8) 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
ANNEX IV
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||
mg active substance/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
|||||||||||||||||||
2b142-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 (1). 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 (2) For the quantification of phytochemical marker d-limonene in the feed additive:
|
Poultry Rabbits Salmonids |
— |
— |
15 |
|
20 March 2032 |
||||||||||
Suidae |
— |
— |
33 |
||||||||||||||||
Ruminants |
— |
— |
30 |
||||||||||||||||
Horses |
— |
— |
40 |
||||||||||||||||
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds |
— |
— |
15 |
(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
ELI: http://data.europa.eu/eli/reg_impl/2024/239/oj
ISSN 1977-0677 (electronic edition)