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Official Journal EN
of the European Union L series
2025/159 30.1.2025
COMMISSION IMPLEMENTING REGULATION (EU) 2025/159
of 29 January 2025
concerning the renewal of the authorisation of a preparation of Pediococcus pentosaceus DSM 14021
as a feed additive for all animal species and repealing Implementing Regulation (EU) No 84/2014
(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 and renewing such authorisation.
(2) The preparation of Pediococcus pentosaceus DSM 14021 was authorised for a period of 10 years as a feed additive for
all animal species by Commission Implementing Regulation (EU) No 84/2014(2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of
the authorisation of the preparation of Pediococcus pentosaceus DSM 14021 as a feed additive for all animal species,
requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group
‘silage additives’. That application was accompanied by the particulars and documents required under Article 14(2)
of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 March 2024(3) that the
preparation of Pediococcus pentosaceus DSM 14021 remains safe for all target animal species, the consumers and the
environment under the conditions of use currently authorised. It also concluded that the additive should be
considered as a potential skin and respiratory sensitizer, that any exposure through skin and respiratory tract is
considered a risk and it could not conclude on the eye irritation potential of the additive due to the lack of data. The
Authority also indicated that there is no need for assessing the efficacy of the additive, as the application for renewal
does not include a proposal for amending or supplementing the conditions of the original authorisation which
would have an impact on the efficacy of the additive.
(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and
recommendations reached in the assessment carried out regarding the method of analysis of the preparation of
Pediococcus pentosaceus DSM 14021 as a feed additive in the context of the previous authorisation are valid and
applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC)
No 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required.
(1) OJ L 268, 18.10.2003, p. 29, ELI: https://eur-lex.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Implementing Regulation (EU) No 84/2014 of 30 January 2014 concerning the authorisation of preparations of
Pediococcus pentosaceus DSM 14021, Pediococcus pentosaceus DSM 23688 or Pediococcus pentosaceus DSM 23689 as feed additives for all
animal species (OJ L 28, 31.1.2014, p. 30, ELI: http://data.europa.eu/eli/reg_impl/2014/84/oj).
(3) EFSA Journal, 22(4), e8706.
(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).
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OJ L, 30.1.2025
(6) In view of the above, the Commission considers that the preparation of Pediococcus pentosaceus DSM 14021 satisfies
the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of
that additive should be renewed. 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. Those protective measures
should be without prejudice to other workers’ safety requirements under Union law.
(7) As a consequence of the renewal of the authorisation of the preparation of Pediococcus pentosaceus DSM 14021 as a
feed additive, Implementing Regulation (EU) No 84/2014 should be repealed.
(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
Renewal of the authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and
to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal of Implementing Regulation (EU) No 84/2014
Implementing Regulation (EU) No 84/2014 is repealed.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 January 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/159/ojANNEX
Identifica- Minimum Maximum
tion Species or content content
Composition, chemical formula, Maximum End of period of
number of Additive category Other provisions
description, analytical method age authorisation
the feed of animal
CFU/kg of fresh material
additive
Category: technological additives. Functional group: silage additives
1k1009 Pediococcus Additive composition All - - - 1. In the directions for use of 19 February
pentosaceus DSM Preparation of Pediococcus pentosaceus animal the additive and 2035
14021 DSM 14021 containing a minimum of species premixtures, the storage
1 × 1011 CFU/g additive conditions shall be indicated.
2. The additive shall only be
used in easy and moderately
Solid form
difficult to ensile fresh
———————————
material(2).
Characterisation of the active substance 3. Minimum dose of the
Viable cells of Pediococcus pentosaceus additive, when it is not used
DSM 14021 in combination with other
——————————— micro-organisms as silage
additives: 1 × 108 CFU/kg
Analytical method(1)
fresh material.
Enumeration in the feed additive of
4. For users of the additive and
Pediococcus pentosaceus DSM 14021:
premixtures, feed business
— Spread plate method on MRS agar operators shall establish
(EN 15786). operational procedures and
organisational measures to
Identification of Pediococcus pentosaceus
address potential risks
DSM 14021:
resulting from their use.
— Pulsed Field Gel Electrophoresis Where those risks cannot be
(PFGE) - CEN/TS 17697 or DNA eliminated by such
sequencing methods. procedures and measures,
the additive and premixtures
shall be used with personal
skin, eye and breathing
protective equipment.
(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.
(2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC)
No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of
applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1, , ELI: http://data.europa.eu/eli/reg/2008/429/oj).
ELI:
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