Commission Implementing Regulation (EU) 2023/2734 of 7 December 2023 concerning the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, dairy ruminants and pigs (holder of authorisation: Mazzoleni S.p.A.)

Official Journal EN of the European Union L series 2023/2734 8.12.2023 COMMISSION IMPLEMENTING REGULATION (EU) 2023/2734 of 7 December 2023 concerning the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, dairy ruminants and pigs (holder of authorisation: Mazzoleni 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 DBVPG 48 SF as a feed additive. 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 a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, ruminants and all pigs, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’ as regards horses, and in the functional group ‘other zootechnical additives’ as regards ruminants and pigs.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 March 2023(2)that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae DBVPG 48 SF is safe for horses, ruminants and all pigs, consumers and the environment. It also concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF is not irritant to the eyes and skin but should be considered a respiratory sensitiser, while it could not conclude on the skin sensitisation potential of that preparation. The Authority further concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs, but was not in the position to conclude on the efficacy of that preparation for ruminants other than dairy ruminants. It did not consider that there is a need for specific requirements of post- market monitoring. The Authority 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 applicant committed on 13 June 2023 to submit supplementary information with a view to demonstrate the efficacy of the preparation of Saccharomyces cerevisiae DBVPG 48 SF for ruminants other than dairy ruminants.

(6) In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae DBVPG 48 SF satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003 for horses, dairy ruminants and all pigs. Accordingly, the use of that preparation should be authorised for horses, dairy ruminants and all pigs. 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) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1) OJ L 268, 18.10.2003, p. 29.

(2) EFSA Journal 2023;21(4):7971.

ELI: http://data.europa.eu/eli/reg_impl/2023/2734/oj 1/4EN OJ L, 8.12.2023

HAS ADOPTED THIS REGULATION:

Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘digestibility enhancers’ and ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 December 2023.

For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2023/2734/ojELI:

http://data.europa.eu/eli/reg_impl/2023/2734/oj 3/4 ANNEX Minimum Maximum Identifi- content content cation Name of the Species or Composition, chemical formula, description, Maximum End of period of number holder of Additive category of Other provisions analytical method age CFU/kg of complete authorisation of the authorisation animal feedingstuff with a additive moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4d24 Mazzoleni Saccharomyces Additive composition Horses - 3 × 109 - 1. In the directions for use of the 28 December S.p.A. cerevisiae DBVPG additive and premixture, the 2033 48 SF Preparation of Saccharomyces cerevisiae storage conditions and stabi­ DBVPG 48 SF with a minimum lity to heat treatment shall be

concentration of: indicated.

1 × 109 CFU/g of additive. 2. For users of the additive and Solid forms. premixtures, feed business op­ erators shall establish opera­ Characterisation of the active substance tional procedures and organi­ sational measures to address Viable cells of Saccharomyces cerevisiae potential risks resulting from DBVPG 48 SF. their use. Where those risks cannot be eliminated by such Analytical method(1) procedures and measures, the additive and premixtures shall — Identification: polymerase chain be used with personal breath­ reaction (PCR) method – CEN/TS ing and skin protective equip­ 15790 ment.

— Enumeration in the feed additive,

premixtures and compound feed: pour or spread plate method (EN

15789) OJ L,

8.12.2023 EN4/4

ELI:

http://data.europa.eu/eli/reg_impl/2023/2734/oj Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d24 Mazzoleni Saccharomyces Additive composition Dairy cows - 4 × 108 - 1. In the directions for use of the 28 December S.p.A. cerevisiae DBVPG All minor additive and premixture, the 2033 48 SF Preparation of Saccharomyces cerevisiae dairy rumi­ storage conditions and stabi­ DBVPG 48 SF with a minimum nants lity to heat treatment shall be

concentration of: indicated.

Pigs for fat­ 4 × 109 1 × 109 CFU/g of additive. 2. For users of the additive and tening Solid forms. premixtures, feed business op­ Piglets (suck­ erators shall establish opera­ ling and Characterisation of the active substance tional procedures and organi­ weaned) sational measures to address Minor por­ Viable cells of Saccharomyces cerevisiae potential risks resulting from cine species DBVPG 48 SF. their use. Where those risks (suckling pig­ cannot be eliminated by such lets, weaned Analytical method(1) procedures and measures, the piglets and additive and premixtures shall pigs for fat­ be used with personal breath­ — Identification: polymerase chain tening) ing and skin protective equip­ reaction (PCR) method – CEN/TS ment.

15790 Sows for 6 × 109 — Enumeration in the feed additive, reproduction

premixtures and compound feed: Minor por­ pour or spread plate method (EN cine species

15789) (sows for reproduc­ tion)

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en EN OJ L,

8.12.2023