Commission Implementing Regulation (EU) 2024/261 of 17 January 2024 concerning the authorisation of black pepper essential oil and black pepper oleoresin from Piper nigrum L. as feed additives for all animal species and black pepper supercritical extract from Piper nigrum L. as a feed additive for cats and dogs

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 those substances, which are produced and labelled before 7 August 2024 in accordance with the rules applicable before 7 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 7 February 2025 in accordance with the rules applicable before 7 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 7 February 2026 in accordance with the rules applicable before 7 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.

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 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 2b347-eo Black pepper essential oil Additive composition Black pepper essential oil obtained from fruits of Piper nigrum L. Liquid form Characterisation of the active substance Black pepper essential oil obtained by steam distillation of dried and crushed unripe fruits from Piper nigrum L. as defined by the Council of Europe  ( 1 ) . Specifications: — b-Caryophyllene: 12-40 % — Limonene: 7-20 % — Sabinene (4(10)-thujene): 4-17 % — a-Pinene (pin-2(3)-ene): 2,5-16 % — Safrole: ≤ 0,0003 % CAS number: 8006-82-4 FEMA number: 2845 CoE number: 347 Analytical method  ( 2 ) For the determination of the phytochemical marker β-caryophyllene: gas chromatography coupled with flame ionisation detection (GC-FID)) based on ISO 3061. All animal species — — — 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 %: — 5 mg for chickens for fattening and minor poultry for fattening — 7 mg for turkeys for fattening — 8 mg for poultry for laying and breeding purposes, — 9,5 mg for piglets, piglets of minor Suidae and pigs for fattening of minor Suidae — 11,5 mg for pigs for fattening — 14 mg for sows — 14 mg for dairy cows and minor dairy ruminants, except dairy sheep and goats — 20 mg for ruminants for fattening, except sheep and goats — 20 mg for sheep and goats — 20 mg for horses — 8,5 mg for rabbits — 20 mg for fish — 20 mg for dogs and cats — 5 mg for ornamental birds — 5 mg for other animal species and categories.’ 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 content 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 7 February 2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authorisation mg of the active substance/kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b347-ex Black pepper supercritical extract Additive composition Black pepper supercritical extract obtained from fruits of Piper nigrum L. Liquid form Characterisation of the active substance Black pepper supercritical extract obtained by CO 2 supercritical extraction from the dried and crushed unripe fruits of Piper nigrum L. (with no additional solvent addition) as defined by the Council of Europe  ( 3 ) . Specifications: — β-Caryophyllene: 8-30 % — Limonene: 10-18 % — Sabinene (4(10)-thujene): 5-17 % — α-Pinene (pin-2(3)-ene):7-18 % — Safrole: ≤ 0,0003 % CoE number: 347 Analytical method  ( 4 ) For the determination of the phytochemical marker β-caryophyllene: gas chromatography coupled with flame ionisation detection (GC-FID) based on ISO 3061. Cats and dogs — — — 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 %: 1,5 mg for cats and dogs.’ 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 content 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 7 February 2034 Identification number of the additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maxi-mum age Minimum content Maximum content Other provisions End of period of authorisation mg of the active substance/kg of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b347-or Black pepper oleoresin Additive composition Preparation of black pepper oleoresin obtained from fruits of Piper nigrum L. Liquid form Characterisation of the active substance Black pepper oleoresin produced by organic solvent extraction of the dried unripe fruits of Piper nigrum L. as defined by the Council of Europe  ( 5 ) . Specifications: — Piperine: 20-50 % — Safrole: ≤ 0,0003 % CAS number: 84929–41-9 FEMA number: 2846 CoE number: 347 Analytical method  ( 6 ) For the determination of the phytochemical marker piperine: high performance liquid chromatography coupled to photometric detection (HPLC-UV) based on ISO 11027. All animal species — — — 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 %: — 1 mg for chickens for fattening and minor poultry species for fattening, — 1,3 mg for turkeys for fattening — 1,4 mg for poultry for laying and breeding purposes — 1,7 mg for piglets, piglets of minor S uidae and pigs for fattening of minor Suidae — 2 mg for pigs for fattening. — 2,5 mg for sows — 2,4 mg for dairy cows and minor dairy ruminants, except dairy sheep and goats — 12,5 mg for calves for fattening — 11,5 for ruminants for fattening except sheep and goats — 11,5 mg for sheep and goats — 11,5 mg for horses — 1,5 mg for rabbits — 13,5 mg for salmonids and minor fin fish — 51,5 mg for ornamental fish — 14 mg for dogs — 3,8 mg for cats — 1 mg for ornamental birds — 1 mg for other animal species or categories.’ 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 content 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 7 February 2034 ( 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