Commission Implementing Regulation (EU) 2022/271 of 23 February 2022 correcting Implementing Regulation (EU) 2020/1760 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

L 43/10 EN Official Journal of the European Union 24.2.2022 COMMISSION IMPLEMENTING REGULATION (EU) 2022/271 of 23 February 2022 correcting Implementing Regulation (EU) 2020/1760 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (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) The use of Bacillus subtilis DSM 25841 as a feed additive was authorised for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets by Commission Implementing Regulation (EU) 2020/1760(2)for a 10-year period. (2) In the Annex to Implementing Regulation (EU) 2020/1760, a wrong identification number was inserted in the column ‘Identification number of the additive’. (3) Implementing Regulation (EU) 2020/1760 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation by the corrected version thereof. (4) In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of the authorisation, a transitional period should be provided for as regards the placing on the market of those products. (5) In order to preserve the legitimate expectations of the interested parties in relation to the terms of the authorisation of the additive, this Regulation should enter into force as a matter of urgency. (6) 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 The Annex to Implementing Regulation (EU) 2020/1760 is replaced by the Annex to this Regulation. Article 2 1. The preparation specified in the Annex and premixtures containing that substance, which are produced and labelled before 25 August 2022in accordance with the rules applicable before 25 February 2022may continue to be placed on the market until the existing stocks are exhausted. (1) OJ L 268, 18.10.2003, p. 29. (2) Commission Implementing Regulation (EU) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (OJ L 397, 26.11.2020, p. 6).24.2.2022 EN Official Journal of the European Union L 43/11 2. Feed materials and compound feed containing the preparation and premixtures referred to in paragraph 1 which are produced and labelled before 25 February 2023 in accordance with the rules applicable before 25 February 2022 may continue to be placed on the market until the existing stocks are exhausted. Article 3 This Regulation shall enter into force on the 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, 23 February 2022. For the Commission The President Ursula VON DER LEYENANNEX Minimum Maximum Minimum Maximum Name of content content content content Identifica- the holder Species or End of period tion Composition, chemical formula, Maxi- of Additive category of CFU/kg of complete Other provisions of number of description, analytical method mum age authorisa- animal feedingstuff with a CFU/l of water for authorisation the additive tion moisture content of drinking 12 % Category of zootechnical additives. Functional group: gut flora stabilisers 4b1902 Chr. Bacillus Additive composition All porcine - 5 × 108 - 1,7 × 108 - 1. In the directions for use 16.12.2030 Hansen subtilis species, of the additive and pre­ Preparation of Bacillus subtilis DSM A/S DSM including mixtures, the storage 25841 containing a minimum of 25841 sows, conditions and stabi­ 1,25 × 1010 CFU/g of additive other than lity to heat treatment Solid form lactating sows shall be indicated. in order to Characterisation of the active substance have a benefit 2. The additive may be Viable spores of Bacillus subtilis DSM in suckling used in water for drink­ 25841 piglets ing. Analytical method(1) 3. For use of the additive in water for drinking For identification of Bacillus subtilis the homogenous dis­ DSM 25841: Identification: Pulsed persion of the additive Field Gel Electrophoresis (PFGE) shall be ensured. For enumeration of Bacillus subtilis DSM 25841 in the feed additive, 4. For users of the addi­ premixtures and feedingstuffs: Spread tive and premixtures, plate method using tryptone soya feed business operators agar – EN 15784 shall establish opera­ tional procedures and organisational mea­ sures to address poten­ tial risks resulting from L 43/12 EN Official Journal of the European Union 24.2.2022its use: a potential re­ spiratory sensitiser, po­ tential skin irritant and potential eyes or der­ mal sensitiser. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ sures, the additive and premixtures shall be used with personal protective equipment. (1) 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 24.2.2022 EN Official Journal of the European Union L 43/13