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 (Text with EEA relevance)

Authorisation

Article 1

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Transitional measures

Article 2

1.   The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 29 March 2023 in accordance with the rules applicable before 29 September 2022 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 as specified in the Annex which are produced and labelled before 29 September 2023 in accordance with the rules applicable before 29 September 2022 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 as specified in the Annex which are produced and labelled before 29 September 2024 in accordance with the rules applicable before 29 September 2022 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.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

ANNEX 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 Chickens for fattening - - 35 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. Mixture of expressed lemon essential oil with other botanical additives is permitted provided that the amounts of perillaldehyde, furocoumarins, and methoxycoumarins in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 29 September 2032 Turkeys for fattening Salmonids 40 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 Laying hens 52 Pigs for fattening 74 Piglets 62 Sows 92 Calves (milk replacers) Cattle for fattening Dairy cows 90 Analytical method  ( 2 ) For the quantification of phytochemical marker d-limonene in the feed additive or in mixture of flavouring compounds: — Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855) Horses 137 Sheep/Goats Rabbits 30 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 Chickens for fattening - - 11 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. Mixture of residual fraction of expressed lemon oil distilled with other botanical additives is permitted provided that the amounts of perillaldehyde, furocoumarins, and methoxycoumarins in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection 29 September 2032 Laying hens Turkeys for fatening Rabbits Salmonids 12 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 The specifications of the active substance are:   d-Limonene 5989-27-5 01.045 51–63 53.3 49.3–56.8   c-Terpinene 99-85-4 01.020 8–17 16.9 12.8–23.3   Geranial 141-27-5 05.188 6–12 10.4 9.5–11.2   Neral 106-26-3 0.8724 5–9 7.8 6.2–8.9   b-Pinene (pin-2(10)-ene) 127-91-3 01.003 0.3–5.5 1.24 0.32–3.38   b-Bisabolene 495-61-4 01.028 0.3–4   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 Ruminants 20 Piglets 20 Pigs for fattening 24 Sows 30 Horses 35 Analytical method  ( 2 ) For the quantification of phytochemical marker d-limonene in the feed additive or in mixture of flavouring compounds: — Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855) 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 Chickens for fattening - - 36 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. Mixture of distilled lemon essential oil (volatile fraction) with other botanical additives is permitted provided that the amounts of 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 29 September 2032 Laying hens 53 Rabbits 56 Turkeys for fattening 48 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  ( 1 ) 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 Piglets 64 Pigs for fattening 76 Sows 94 Calves (milk replacers) Cattle for fattening Sheep/Goats 95 Horses 141 Analytical method  ( 2 ) For the quantification of phytochemical marker d-limonene in the feed additive or in mixture of flavouring compounds: — Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 855) Dairy cows 91 Salmonids Ornamental fish Dogs 60 Cats 30 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 Chickens for fattening - - 8,5 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. Mixture of distilled lime essential oil with other botanical additives is permitted provided that the amounts of 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. 29 September 2032 Laying hens 12,5 Turkeys for fatening 11 Piglets 15 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  ( 1 ) 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 Pigs for fattening 18 Lactating sows 22 Cattle for fattening 33,5 Calves (milk replacers) 35,5 Dairy cows 21,5 Sheep/Goats Horses 33,5 Rabbits 13,5 Salmonids Ornamental fish 30 Analytical method  ( 2 ) For the quantification of phytochemical marker d-limonene in the feed additive or in mixture of flavouring compounds: — 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