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)
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/regulation/2024/239@2024-01-15/en
Contents
- Preamble
- Article 1 Correction and amendment to Implementing Regulation (EU) 2022/1421
- 2.
- Article 2 Correction and amendment to Implementing Regulation (EU) 2022/652
- 1.
- Article 3 Correction and amendment to Implementing Regulation (EU) 2022/1490
- 1.
- Article 4 Correction and amendment to Implementing Regulation (EU) 2022/320
- 2.
- ANNEX
- ANNEX I
- ANNEX II
- ANNEX III
- ANNEX IV
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, 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 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, 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 for a 10-year period. In its opinion of 23 June 2021, 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 for a 10-year period. In its opinion of 18 March 2021, 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 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, 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 1 Correction and amendment to Implementing Regulation (EU) 2022/1421
2.
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.
Article 1 Correction and amendment to Implementing Regulation (EU) 2022/1421
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 Correction and amendment to Implementing Regulation (EU) 2022/652
1.
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.
Article 2 Correction and amendment to Implementing Regulation (EU) 2022/652
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 3 Correction and amendment to Implementing Regulation (EU) 2022/1490
1.
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.
Article 3 Correction and amendment to Implementing Regulation (EU) 2022/1490
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 4 Correction and amendment to Implementing Regulation (EU) 2022/320
2.
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.
Article 4 Correction and amendment to Implementing Regulation (EU) 2022/320
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
ANNEX
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. Liquid form Characterisation of the active substance Essential oil derived by cold expression from fruit peel of Citrus sinensis (L.) Osbeck as defined by the Council of Europe. In the volatile fraction: d-Limonene: 93-97 % Myrcene: 1,5-3,5 % Sabinene: 0,1-1,0 % α-Pinene: 0,4-0,8 % Linalool: 0,1-0,7 % Decanal: 0,1-0,7 % Octanal: 0,1-0,6 % Perillaldehyde: < 0,05 % CAS number: 8028-48-6 Einecs number: 232-433-8 FEMA number: 2825 CoE number: 143 Analytical method For the determination of d-limonene (phytochemical marker) in the feed additive: 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. d-Limonene: 93-97,5 % Myrcene: 1,5-3,5 % Sabinene: 0,2-1,0 % α-Pinene: 0,3-0,8 % Linalool: 0,05-0,5 % Octanal: 0,05-0,4 % Perillaldehyde: < 0,005 % CAS number: 8028-48-6 CoE number: 143 Analytical method For the determination of d-limonene (phytochemical marker) in the feed additive: 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. Non-volatile fraction: 10,5 % In the volatile fraction: d-Limonene: 89-96 % Decanal: 0,5-2 % Linalool: 0,7-1,7 % Myrcene: 0,1-1,0 % Geranial: 0,1-1,0 % Perillaldehyde: < 0,3 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method For the determination of d-limonene (phytochemical marker) in the feed additive: 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. Non-volatile fraction: 20,9 % In the volatile fraction: d-Limonene: 79-89 % Decanal: 3,0-5,0 % Linalool: 2,0-5,0 % Myrcene: 0,1-1,0 % Geranial: 0,5-1,8 % Perillaldehyde: < 0,6 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method For the determination of d-limonene (phytochemical marker) in the feed additive: 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. Non-volatile fraction: 18 % In the volatile fraction: d-Limonene: 85-95 % Linalool: 0,5-4 % CAS number: 8028-48-6 FEMA number: 2822 Analytical method For the determination of d-limonene (phytochemical marker) in the feed additive: All animal species except horses, rabbits, dogs, cats, ornamental fish and ornamental birds — — — 12 September 2032
gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animal.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animals.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animals.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 11024)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture with other botanical additives is permitted provided that the amounts of perillaldehyde added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animals.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3140)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. On the label of the additive the following shall be indicated: Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:
Chickens for fattening and minor poultry species for fattening, laying hens and minor poultry species for laying and breeding, turkeys for fattening, Suidae: 50 mg;
Calves (milk replacer), sheep, goats: 70 mg;
Ruminants except sheep and goats: 60 mg;
Other animal species and categories except horses, rabbits, dogs, cats, ornamental fish and ornamental birds: 2 mg.
4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.
5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
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. Flavonoids: 45-55 % of which 5-methoxypsoralen (also known as bergapten): ≤ 0,03 % (-)-Synephrine: ≤ 1 % CoE number: 136 Analytical method For the quantification of naringin (phytochemical marker) in the feed additive: All animal species except dogs, cats, ornamental fish and ornamental birds — — 11 May 2032
Naringin: 20-30 %
Neohesperidin: 10-20 %
High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. On the label of the additive the following shall be indicated: Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:
Chickens for fattening and minor poultry species for fattening: 102 mg;
Laying hens and minor poultry species for laying or breeding: 151 mg;
Turkeys for fattening: 136 mg;
Piglets of all Suidae species: 182 mg;
All Suidae for fattening: 217 mg;
Sows of all Suidae species: 268 mg;
Dairy ruminants other than dairy sheep and dairy goats: 259 mg;
Calves (milk replacer), sheep, goats, other ruminants for fattening, horses, salmonids and all other fin fish: 400 mg;
Rabbits: 161 mg;
Other animal species and categories except dogs, cats, ornamental fish and ornamental birds: 102 mg.
4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.
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 feedingstuffs.
7. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
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 d-Limonene: 60–73 % β-Pinene (pin-2(10)-ene): 9–18 % γ-Terpinene: 6–12 % α-Pinene (pin-2(3)-ene): 1,3–3,0 % Sabinene (4(10)-thujene): 0,3–3,0 % Geranial: 0,1–2,0 % Neral: 0,1–1,8 % Perillaldehyde: ≤ 0,023 % Furocoumarins: ≤ 0,3 % Methoxycoumarins: ≤ 0,06 % CAS number 84929-31-7 FEMA number 2625 CoE number: 139 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: 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 The specifications of the active substance are: d-Limonene: 51–63 % γ-Terpinene: 8–17 % Geranial: 6–12 % Neral:5–9 % β-Pinene (pin-2(10)-ene): 0,3–5,5 % β-Bisabolene: 0,3–4 % Perillaldehyde: ≤ 0,092 % Furocoumarins: ≤ 0,8 % Methoxycoumarins: ≤ 0,22 % CoE number: 139 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: 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 The specifications of the active substance are: d-Limonene: 66–78 % β-Pinene (pin-2(10)-ene): 5–20 % γ-Terpinene: 1,5–9,5 % α-Pinene (pin-2(3)-ene): 0.5–3,0 % Sabinene: 0,3–3,0 % Furocoumarins: ≤ 0,1 mg/kg Methoxycoumarins: ≤ 0,1 mg/kg CoE number: 139 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: 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 The specifications of the active substance are: d-Limonene: 45–52 % γ-Terpinene: 10–14 % Terpinolene: 5,5–10,5 % αΤerpineol: 6–8 % β-Caryophyllene: 0,2–0,8 % Furocoumarins: ≤ 0,0083 % Methoxycoumarins: ≤ 0,03 % CoE number:141 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: 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
Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture of expressed lemon essential oil with other botanical additives is permitted provided that the amounts of perillaldehyde, furocoumarins, and methoxycoumarins in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment,.
Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture of residual fraction of expressed lemon oil distilled with other botanical additives is permitted provided that the amounts of perillaldehyde, furocoumarins, and methoxycoumarins in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture of distilled lemon essential oil (volatile fraction) with other botanical additives is permitted provided that the amounts of furocoumarins, and methoxycoumarins in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3519)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture of distilled lime essential oil with other botanical additives is permitted provided that the amounts of furocoumarins, and methoxycoumarins in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
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. d-Limonene: 65–80 % γ-Terpinene: 13-22 % α-Pinene (pin-2(3)-ene): 1-3,5 % Myrcene:1-2 % β-Pinene (pin-2(10)-ene): 1-2 %. Methyl N-methyl anthranilate: 0,15-0,7 % Perillaldehyde: ≤ 0,063 % CAS number: 8008-31-9 FEMA number: 2657 CoE number: 142 Analytical method For the quantification of phytochemical marker d-limonene in the feed additive: 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
Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3528)
1. The additive shall be incorporated into the feed in the form of a premixture.
2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3. Mixture of expressed mandarin essential oil with other botanical additives is permitted provided that the amounts of perillaldehyde in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category.
4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.