Commission Implementing Regulation (EU) 2023/2846 of 20 December 2023 concerning the authorisation of red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. as a feed additive for all animal species

Official Journal EN of the European Union L series 2023/2846 21.12.2023 COMMISSION IMPLEMENTING REGULATION (EU) 2023/2846 of 20 December 2023 concerning the authorisation of red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. as a feed additive for all animal species (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 substance red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of Feed Additives as an existing product 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 red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (4) The applicant requested the additive 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 this additive in water for drinking should not be allowed. (5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 22 November 2022(3)that, under the proposed conditions of use, red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. is safe for all animal species, for consumers and the environment. It also concluded that the extract under assessment is not an eye irritant but that in the absence of data, no conclusion can be drawn on its potential to be a skin irritant and a dermal and respiratory sensitiser. It further concluded that since the substance is recognised to flavour food and since its 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 additive 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(12):7699. ELI: http://data.europa.eu/eli/reg_impl/2023/2846/oj 1/5EN OJ L, 21.12.2023 (6) In view of the above, the Commission considers that red quebracho extract from Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of this substance should be authorised. The Commission considers that due to the possible effect of this extract as medicinal product and other possible zootechnical effects thereof, a maximum level should be set in order to prevent this additive from being used for other purposes. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. (7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance 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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Transitional measures 1. The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 10 July 2024 in accordance with the rules applicable before 10 January 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 10 January 2025in accordance with the rules applicable before 10 January 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 substance specified in the Annex which are produced and labelled before 10 January 2026in accordance with the rules applicable before 10 January 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. 2/5 ELI: http://data.europa.eu/eli/reg_impl/2023/2846/ojEN OJ L, 21.12.2023 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 December 2023. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2023/2846/oj 3/54/5 ELI: http://data.europa.eu/eli/reg_impl/2023/2846/oj ANNEX Maximum Minimum Maximum age content content Identification Composition, chemical formula, description, Species or category of mg active End of period of number of the Additive Other provisions analytical method animal substance/kg of authorisation additive complete feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b2972-ex Red Additive composition Turkeys for — — 540 1. The additive shall be incorpo­ 10 January 2034 quebracho fattening rated into the feed in the form Wood extract of either Schinopsis balansae Engl. or extract of a premixture. Schinopsis lorentzii (Griseb.) Engl. Solid form Chickens for — — 400 Characterisation of the active substance fattening and minor poultry for Extract of condensed tannins from red quebracho fattening Extract obtained from wood of either Schinopsis balansae Engl. or Schinopsis lorentzii (Griseb.) Engl. 2. In the directions for use of the by steam under pressure, further filtration, All poultry species — — 600 additive and premixtures, the concentration and spray drying of the for laying and storage conditions and stabi­ concentrated solution as defined by the Council breeding purposes. lity to heat treatment shall be of Europe(1) indicated. Specifications Condensed tannins: 70-87 % Piglets, piglets of — — 720 minor Suidae and CAS number: 90106-04-0 for Schinopsis lorentzii pigs for fattening of (Griseb.) Engl. minor Suidae FEMA number: 2972 3. Mixture of red quebracho ex­ Pigs for fattening — — 860 tract with other botanical ad­ ditives is permitted provided that the amounts of con­ densed tannins in feed materi­ Sows — — 1 050 als and compound feed are lower than the one resulting from the use of a single addi­ Veal calves (milk — — 1 680 tive at the maximum or re­ replacer) commended level for the spe­ cies or animal category. EN OJ L, 21.12.2023ELI: http://data.europa.eu/eli/reg_impl/2023/2846/oj 5/5 Ruminants for — — 1 580 Analytical method(2) 4. For users of the additive and fattening except premixtures, feed business For the quantification of condensed tannins sheep and goats operators shall establish op­ (phytochemical marker) in the feed additive: Horses erational procedures and or­ indirect gravimetric analysis of tanning agents ganisational measures to ad­ with fixing of the absorbent compounds in low dress the potential risks chromed hide powder – ISO 14088 Sheep, goats — — 1 580 resulting from their use. Where those risks cannot be Dairy cows and — — 1 030 eliminated by such proce­ minor dairy dures and measures, the addi­ ruminants except tive and premixtures shall be dairy sheep and used with personal breathing, goat eye and skin protective equip­ ment. Rabbits — — 630 Salmonids and — — 1 810 minor finfish Ornamental fish — — 3 000 Dogs — — 1 900 Ornamental birds 317 Cats — — 317 Other animal — — 317 species and categories (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, 21.12.2023 EN