Commission Implementing Regulation (EU) 2022/272 of 23 February 2022 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for all suidae other than weaned piglets and sows, and dogs (holder of authorisation: Prosol S.p.A.) (Text with EEA relevance)

L 43/14 EN Official Journal of the European Union 24.2.2022 COMMISSION IMPLEMENTING REGULATION (EU) 2022/272 of 23 February 2022 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for all suidae other than weaned piglets and sows, and dogs (holder of authorisation: Prosol S.p.A.) (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 an authorisation. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for all suidae other than weaned piglets and sows, and dogs, to be classified in the category ‘zootechnical additives’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 June 2021(2)(3)that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae MUCL 39885 does not have adverse effects on animal health, consumer safety or the environment. It also concluded that this preparation is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that in the case of suidae, the preparation has the potential to be efficacious as a zootechnical additive in feedingstuffs and in the case of dogs, the preparation has the potential to be efficacious in improving the faecal consistency. The Authority does not consider that there is a need for specific requirements of postmarket monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (5) The assessment of the preparation of Saccharomyces cerevisiae MUCL 39885 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. (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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. (1) OJ L 268, 18.10.2003, p. 29. (2) EFSA Journal 2021;19(7):6698. (3) EFSA Journal 2021;19(7):6699.24.2.2022 EN Official Journal of the European Union L 43/15 Article 2 This Regulation shall enter into force on the twentieth 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 Mini- Maxi- mum mum Identifica- Name of content content tion the Maxi- Composition, chemical formula, Species or category of End of period of number of holder of Additive mum Other provisions description, analytical method animal CFU/kg of complete authorisation the authori- age feedingstuff with a additive sation moisture content of 12 % Category: zootechnical additives. Functional group: gut flora stabilisers 4b1710 Prosol Saccharomyces Additive composition All Suidae other than - 3 × 109 - 1. In the directions for use of the additive 16.3.2032 S.p.A. cerevisiae Preparation of Saccharomyces cerevisiae for reproduction and premixtures, the storage conditions MUCL 39885 MUCL 39885 purposes and weaned and stability to heat treatment shall be containing a minimum of: piglets indicated. 1 × 109 CFU/g of additive All Suidae for - Solid form reproduction - 6,4 × 2. For users of the additive and premixtures, Characterisation of the active substance purposes other than 109 feed business operators shall establish Viable cells of Saccharomyces cerevisiae sows operational procedures and appropriate MUCL 39885 Dogs organisational measures to address ha­ Analytical method(1) - zards by inhalation, dermal contact or Enumeration: pour plate method - eyes contact. Where the dermal, inhala­ using yeast extract glucose tion or eyes exposure cannot be elimi­ chloramphenicol agar (CGYE) (EN 7 × 1010 nated or reduced to a minimum by such 15789) procedures and measures, the additive Identification: polymerase chain and premixtures shall be used with ap­ reaction (PCR) method propriate personal protective equip­ ment, including skin, eyes and breathing protection. (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 L 43/16 EN Official Journal of the European Union 24.2.2022