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Official Journal EN
of the European Union L series
2024/980 3.4.2024
COMMISSION IMPLEMENTING REGULATION (EU) 2024/980
of 2 April 2024
concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed
additive for cats (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 a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed
additive for cats, requesting that additive to be classified in the category ‘zootechnical additives’ and in the
functional group ‘gut flora stabilisers’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 June 2021(2) and of
26 September 2023(3)that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae MUCL
39885 is safe for cats. It also concluded that the preparation of Saccharomyces cerevisiae MUCL 39885 is considered a
potential skin and eye irritant and a skin and respiratory sensitiser. The Authority further concluded that the
preparation of Saccharomyces cerevisiae MUCL 39885, has the potential to be efficacious as a zootechnical additive for
cats when added to feed at 7 × 1010 CFU/kg complete feed. It did not consider that there is a need for specific
requirements of post-market monitoring.
(5) In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(4), the Reference
Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations
reached in a previous assessment concerning the same additive are valid and applicable for the current application.
(6) In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae MUCL 39885 satisfies
the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation
should be authorised for cats. 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, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal 2021;19(7):6699.
(3) EFSA Journal 2023;21(10):8358.
(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC)
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference
Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/
2005/378/oj).
ELI: http://data.europa.eu/eli/reg_impl/2024/980/oj 1/3EN
OJ L, 3.4.2024
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
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.
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, 2 April 2024.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2024/980/ojELI:
http://data.europa.eu/eli/reg_impl/2024/980/oj
3/3
ANNEX
Minimum Maximum
Identifica-
content content
tion Name of the Species or
Composition, chemical formula, Maximum End of period of
number of holder of Additive category of Other provisions
description, analytical method age CFU/kg of complete authorisation
the feed authorisation animal
feedingstuff with a
additive
moisture content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1710 Prosol S.p.A Saccharomyces Additive composition Cats — 7 × 1010 — 1. In the directions for use of the additive 23 April 2034
cerevisiae and premixture, the storage conditions
Preparation of Saccharomyces cerevisiae
MUCL 39885 and stability to heat treatment shall be
MUCL 39885
indicated.
containing a minimum of:
2. For users of the additive and premix
1 × 109 CFU/g of additive
tures, feed business operators shall es
Solid form
tablish operational procedures and or
ganisational measures to address
Characterisation of the active potential risks resulting from their
substance use. Where those risks cannot be elimi
Viable cells of Saccharomyces cerevisiae nated by such procedures and mea
MUCL 39885 sures, the additive and premixtures
shall be used with personal breathing,
Analytical method(1) eye and skin protective equipment.
Identification: polymerase chain
reaction (PCR) method – CEN/TS
15790.
Enumeration in feed additive and
compound feed: Pour or spread plate
method (EN 15789).
(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
OJ
L,
3.4.2024
EN