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

Official Journal EN of the European Union L series 2024/261 18.1.2024 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 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on additives for use in animal nutrition(1), and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2). (2) The substances black pepper essential oil and black pepper oleoresin from Piper nigrum L. and black pepper supercritical extract from Piper nigrum L. were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These substances were subsequently entered in the Register of Feed Additives as existing products belonging to the category ‘sensory additives’ and to the functional group ‘flavouring compounds’, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003. (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of black pepper essential oil, black pepper oleoresin and black pepper supercritical extract from Piper nigrum L. as feed additives for all animal species, requesting the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant subsequently withdrew the application for authorisation of black pepper supercritical extract from Piper nigrum L. as regards the use for all animal species except cats and dogs. (4) The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of those additives in water for drinking should not be allowed. (5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022(3)that, under the proposed conditions of use, black pepper essential oil, black pepper supercritical extract and black pepper oleoresin from Piper nigrum L. are safe for the target species, consumers and the environment. It also concluded that black pepper essential oil, black pepper supercritical extract and black pepper oleoresin should be considered as irritant to skin and eyes, and as dermal and respiratory sensitisers. The Authority further concluded that since the substances are recognised to flavour food and since their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (1) OJ L 268, 18.10.2003, p. 29. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). (3) EFSA Journal 2022;20(11):7599 ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj 1/9EN OJ L, 18.1.2024 (6) In view of the above, the Commission considers that black pepper essential oil, black pepper oleoresin and black pepper supercritical extract from Piper nigrum L. satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of these substances should be authorised. The Commission considers that safety reasons do not require the setting of maximum levels for the substances concerned. The large margin of exposure and the lack of substances of concern permit to establish maximum recommended contents. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additives. Where such contents are exceeded, certain information should be indicated on the label of the premixtures concerned. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives. (7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. (8) 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 Authorisation 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. Article 2 Transitional measures 1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 7 August 2024in accordance with the rules applicable before 7 February 2024may 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 2025in accordance with the rules applicable before 7 February 2024may 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 2026in accordance with the rules applicable before 7 February 2024may 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 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. 2/9 ELI: http://data.europa.eu/eli/reg_impl/2024/261/ojEN OJ L, 18.1.2024 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 January 2024. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj 3/94/9 ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj ANNEX Minimum Maximum content content Identification Species or Composition, chemical formula, Maximum End of period of number of the Additive category of mg active substance/kg Other provisions description, analytical method age authorisation additive animal of complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b347-eo Black pepper Additive composition All animal — — — 1. The additive shall be incorporated into the feed in 7 February 2034 essential oil species the form of a premixture. Black pepper essential oil obtained 2. In the directions for use of the additive and pre­ from fruits of Piper nigrum L. mixtures, the storage conditions and stability to heat treatment shall be indicated. Liquid form 3. On the label of the additive, the following shall be indicated: Characterisation of the active substance ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a Black pepper essential oil obtained by moisture content of 12 %: steam distillation of dried and — 5 mg for chickens for fattening and minor crushed unripe fruits from Piper poultry for fattening nigrum L. as defined by the Council — 7 mg for turkeys for fattening of Europe(1). — 8 mg for poultry for laying and breeding pur­ poses, Specifications: — 9,5 mg for piglets, piglets of minor Suidae and — b-Caryophyllene: 12-40 % pigs for fattening of minor Suidae — Limonene: 7-20 % — 11,5 mg for pigs for fattening — Sabinene (4(10)-thujene): 4-17 % — 14 mg for sows — a-Pinene (pin-2(3)-ene): 2,5-16 % — 14 mg for dairy cows and minor dairy rumi­ — Safrole: ≤ 0,0003 % nants, except dairy sheep and goats — 20 mg for ruminants for fattening, except CAS number: 8006-82-4 sheep and goats FEMA number: 2845 — 20 mg for sheep and goats CoE number: 347 — 20 mg for horses — 8,5 mg for rabbits — 20 mg for fish EN OJ L, 18.1.2024ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj 5/9 Analytical method(2) — 20 mg for dogs and cats — 5 mg for ornamental birds For the determination of the — 5 mg for other animal species and categories.’ phytochemical marker 4. The functional group, the identification number, β-caryophyllene: gas the name and the added amount of the active chromatography coupled with flame substance shall be indicated on the label of the ionisation detection (GC-FID)) based premixture where the use level on the label of on ISO 3061. the premixture would result in exceeding the con­ tent referred to in point 3. 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to ad­ dress the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and pre­ mixtures shall be used with personal breathing, eye and skin protective equipment. (1) Natural sources of flavourings – Report No 2 (2007). (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports OJ L, 18.1.2024 EN6/9 ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj Minimum Maximum content content Identification Species or Composition, chemical formula, Maxi-mum mg of the active End of period of number of the Additive category of Other provisions description, analytical method age substance/kg of authorisation additive animal complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b347-ex Black pepper Additive composition Cats and — — — 1. The additive shall be incorporated into the feed in 7 February 2034 supercritical dogs the form of a premixture. extract Black pepper supercritical extract 2. In the directions for use of the additive and pre­ obtained from fruits of Piper nigrum L. mixtures, the storage conditions and stability to heat treatment shall be indicated. Liquid form 3. On the label of the additive the following shall be indicated: Characterisation of the active substance ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a Black pepper supercritical extract moisture content of 12 %: 1,5 mg for cats and obtained by CO supercritical dogs.’ 2 extraction from the dried and 4. The functional group, the identification number, crushed unripe fruits of Piper nigrum the name and the added amount of the active L. (with no additional solvent substance shall be indicated on the label of the addition) as defined by the Council premixture where the use level on the label of of Europe(1). the premixture would result in exceeding the con­ tent referred to in point 3. Specifications: 5. For users of the additive and premixtures, feed — β-Caryophyllene: 8-30 % business operators shall establish operational — Limonene: 10-18 % procedures and organisational measures to ad­ — Sabinene (4(10)-thujene): 5-17 % dress the potential risks resulting from their use. — α-Pinene (pin-2(3)-ene):7-18 % Where those risks cannot be eliminated by such — Safrole: ≤ 0,0003 % procedures and measures, the additive and pre­ mixtures shall be used with personal breathing, CoE number: 347 eye and skin protective equipment. EN OJ L, 18.1.2024ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj 7/9 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. (1) Natural sources of flavourings – Report No 2 (2007). (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports OJ L, 18.1.2024 EN8/9 ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj Minimum Maximum content content Identification Species or Composition, chemical formula, Maxi-mum mg of the active End of period of number of the Additive category of Other provisions description, analytical method age substance/kg of authorisation additive animal complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b347-or Black pepper Additive composition All animal — — — 1. The additive shall be incorporated into the feed in 7 February 2034 oleoresin species the form of a premixture. Preparation of black pepper oleoresin 2. In the directions for use of the additive and pre­ obtained from fruits of Piper nigrum L. mixtures, the storage conditions and stability to Liquid form heat treatment shall be indicated. 3. On the label of the additive the following shall be Characterisation of the active substance indicated: ‘Recommended maximum content of the active Black pepper oleoresin produced by substance per kg of complete feedingstuff with a organic solvent extraction of the moisture content of 12 %: dried unripe fruits of Piper nigrum L. — 1 mg for chickens for fattening and minor as defined by the Council of poultry species for fattening, Europe(1). — 1,3 mg for turkeys for fattening — 1,4 mg for poultry for laying and breeding Specifications: purposes — Piperine: 20-50 % — 1,7 mg for piglets, piglets of minor Suidae and — Safrole: ≤ 0,0003 % pigs for fattening of minor Suidae — 2 mg for pigs for fattening. CAS number: 84929–41-9 — 2,5 mg for sows FEMA number: 2846 — 2,4 mg for dairy cows and minor dairy rumi­ CoE number: 347 nants, except dairy sheep and goats — 12,5 mg for calves for fattening Analytical method(2) — 11,5 for ruminants for fattening except sheep and goats For the determination of the — 11,5 mg for sheep and goats phytochemical marker piperine: — 11,5 mg for horses high performance liquid — 1,5 mg for rabbits chromatography coupled to photometric detection (HPLC-UV) based on ISO 11027. EN OJ L, 18.1.2024ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj 9/9 — 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 con­ tent referred to in point 3. 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to ad­ dress the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and pre­ mixtures shall be used with personal breathing, eye and skin protective equipment. (1) Natural sources of flavourings – Report No 2 (2007). (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports OJ L, 18.1.2024 EN