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Official Journal EN
of the European Union L series
2026/553 16.3.2026
COMMISSION IMPLEMENTING REGULATION(EU) 2026/553
of 13 March 2026
amending Implementing Regulations (EU) 2020/1755 and (EU) 2024/1054 as regards the terms of the
authorisation of a preparation of Weizmannia faecalisDSM 32016 as a feed additive for all poultry
species for fattening, reared for breeding and laying and ornamental birds (holder of authorisation:
Biochem Zusatzstoffe Handels- und Produktionsges. mbH)
(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 2003 on
additives for use in animal nutrition(1), and in particular Article 13(3) 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 modifying such authorisation.
(2) A preparation of Weizmannia faecalisDSM 32016 was authorised for a period of 10 years as a feed additive for use in
feed for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds by Commission
Implementing Regulation (EU) 2020/1755(2)and as a feed additive for use in feed and in water for drinking for all
poultry species reared for laying or breeding and for use in water for drinking for all poultry species for fattening,
ornamental birds, suckling and weaned Suidae piglets by Commission Implementing Regulation (EU) 2024/1054(3).
(3) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted on 8 August 2024
for the modification of the terms of the authorisation of the preparation of Weizmannia faecalisDSM 32016 as a feed
additive for use in feed and in water for drinking for all poultry species for fattening, reared for breeding and laying
and ornamental birds, requesting to allow the simultaneous use of that preparation with the coccidiostat amprolium
and a combination of coccidiostats narasin and nicarbazin, which are authorised as feed additives. The request was
accompanied by the relevant supporting data.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of
Weizmannia faecalisDSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry species for fattening and ornamental
birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH) (OJ L 395, 25.11.2020, p. 5; ELI: http://data.
europa.eu/eli/reg_impl/2020/1755/oj).
(3) Commission Implementing Regulation (EU) 2024/1054 of 10 April 2024 concerning the authorisation of a preparation of
Weizmannia faecalis DSM 32016as a feed additive for use in feed and in water for drinking for all poultry species reared for laying or
breeding and for use in water for drinking for all poultry species for fattening, ornamental birds, suckling and weaned Suidae piglets
(holder of the authorisation: Biochem Zusatzstoffe Handels- und Produktionsges. mbH), and amending Implementing Regulation
(EU) 2020/1755 as regards the terms of the authorisation of that preparation (OJ L, 2024/1054, 11.4.2024, ELI: http://data.europa.
eu/eli/reg_impl/2024/1054/oj).
ELI: http://data.europa.eu/eli/reg_impl/2026/553/oj 1/9EN
OJ L, 16.3.2026
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 June 2025(4)that the proposed
modification in the terms of the authorisation of the preparation of Weizmannia faecalis DSM 32016 would not
change the conclusions previously drawn regarding the safety of that additive for the target species, consumers and
the environment. The Authority also concluded that the preparation of Weizmannia faecalisDSM 32016 is not a skin
or eye irritant but should be considered a skin and respiratory sensitiser, and inhalation and dermal exposure are
considered a risk. It also concluded that the use of that preparation is compatible with the coccidiostat amprolium
and the combination of coccidiostats narasin and nicarbazin under the currently authorised conditions of use. The
Authority did not consider that there is a need for specific requirements for a post-market monitoring.
(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and
recommendations reached in a previous assessment concerning another application for the authorisation of the
same additive and verified by the Authority in its opinion of 25 May 2020(5)are valid and applicable for the current
application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(6), an evaluation
report of the Reference Laboratory was therefore not required.
(6) In view of the above, the Commission considers that the preparation of Weizmannia faecalisDSM 32016 still satisfies
the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms of the
authorisation laid down in Implementing Regulations (EU) 2020/1755 and (EU) 2024/1054, by specifying the
compatibility of the use of that preparation with the coccidiostat amprolium and a combination of coccidiostats
narasin and nicarbazin. In addition, considering that those coccidiostats may not be authorised as feed additives for
each of the species or categories listed in Annexes I and II, their simultaneous use with the preparation of
Weizmannia faecalis DSM 32016 should only be possible in accordance with their respective conditions of
authorisation as feed additives.
(7) Implementing Regulations (EU) 2020/1755 and (EU) 2024/1054 should therefore be amended accordingly.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the preparation of Weizmannia faecalis DSM 32016 for all poultry species for fattening, reared for breeding and
laying and ornamental birds, it is appropriate to provide for a transitional period for interested parties to prepare
themselves to meet the new requirements resulting from the modification of the authorisation concerned.
(9) 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
Amendment to Implementing Regulation (EU) 2020/1755
The Annex to Implementing Regulation (EU) 2020/1755 is replaced by Annex I to this Regulation.
(4) EFSA Journal. 2025;23:e9548. https://doi.org/10.2903/j.efsa.2025.9548.
(5) EFSA Journal2020;18(6):6158. https://doi.org/10.2903/j.efsa.2020.6158.
(6) 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).
2/9 ELI: http://data.europa.eu/eli/reg_impl/2026/553/ojEN
OJ L, 16.3.2026
Article 2
Amendment to Implementing Regulation (EU) 2024/1054
The Annex to Implementing Regulation (EU) 2024/1054 is replaced by Annex II to this Regulation.
Article 3
Transitional measures
1. The feed additive Weizmannia faecalisDSM 32016, as authorised by Implementing Regulations (EU) 2020/1755 and
(EU) 2024/1054 and premixtures containing that additive, which are intended for all poultry species for fattening, reared
for breeding and laying and ornamental birds, and which are produced and labelled before 5 October 2026 in accordance
with the rules applicable 5 April 2026 may continue to be placed on the market and used until the stocks concerned are
exhausted.
2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for all
poultry species for fattening, reared for breeding and laying and ornamental birds, and which are produced and labelled
before 5 April 2027 in accordance with the rules applicable before 5 April 2026 may continue to be placed on the market
and used until the stocks concerned are exhausted.
Article 4
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, 13 March 2026.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2026/553/oj 3/9ANNEX I
Minimum Maximum
content content
Identification Composition, chemical
Name of the holder of Name of the Species or category Maximum End of period of
number of formula, description, Other provisions
authorisation additive of animal age CFU/kg of complete feed authorisation
the additive analytical method
with a moisture content
of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1900 Biochem Zusatzstoffe Weizmannia Additive composition Suckling and - 1 × 109 - 1. In the directions for use of 15.12.2030
Handels- und faecalisDSM weaned Suidae the additive and
Preparation of
Produktionsges. mbH 32016 piglets premixtures, the storage
Weizmannia faecalisDSM
conditions and stability
32016 containing a
Poultry for to heat treatment shall be
minimum of 2 × 1010
fattening indicated.
CFU/g additive
Solid form Ornamental 2. The additive may be used
simultaneously with the
birds
following coccidiostats,
Characterisation of the
in accordance with their
active substance
respective conditions of
Viable spores of cells of authorisation as feed
Weizmannia faecalisDSM additives: halofuginone,
32016 diclazuril, monensin
sodium, robenidine
Analytical method(1) hydrochloride,
salinomycin sodium,
Identification: DNA
amprolium, a
sequencing methods or
combination of
Pulsed Field Gel
monensin sodium with
Electrophoresis (PFGE) –
nicarbazin and a
CEN/TS 17697.
combination of narasin
and nicarbazin.
4/9
ELI:
http://data.europa.eu/eli/reg_impl/2026/553/oj
EN
OJ
L,
16.3.2026Minimum Maximum
content content Identification Composition, chemical
Name of the holder of Name of the Species or category Maximum End of period of
number of formula, description, Other provisions
authorisation additive of animal age CFU/kg of complete feed authorisation
the additive analytical method
with a moisture content
of 12 %
Enumeration in the feed 3. For users of the additive
additive, premixtures, and premixtures, feed
compound feed and business operators shall
water for drinking: establish operational
Spread plate method on procedures and
MRS agar (based on EN organisational measures
15787 method). to address potential risks
resulting from their use.
Where those risks cannot
be eliminated by such
procedures and
measures, the additive
and premixtures shall be
used with personal
breathing and skin
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.
ELI:
http://data.europa.eu/eli/reg_impl/2026/553/oj
5/9
OJ
L,
16.3.2026
ENANNEX II
PART I
Mini-
Minimum Maximum Maximum
mum
content content content
Identification Name of the Composition, chemical Species or content End of period
Name of the Maximum
number of holder of formula, description, category of Other provisions of
additive age
the additive authorisation analytical method animal CFU/kg of complete authorisation
CFU/l of water for
feed with a moisture
drinking
content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1900 Biochem Weizmannia Additive composition All poultry - 1 × 109 - 5 × 108 - 1. In the directions for use of 1 May 2034
Zusatzstoffe faecalisDSM species the additive and
Preparation of
Handels- und 32016 reared for premixtures, the storage
Weizmannia faecalis
Produktions laying conditions, the stability to
DSM 32016 containing
ges. mbH heat treatment and the
a minimum of 2 × 1010
All poultry stability in water for
CFU/g additive
species drinking shall be indicated.
Solid form reared for
breeding 2. The additive may be used via
water for drinking.
Characterisation of the
active substance
3. The additive may be used
Viable spores of simultaneously with the
Weizmannia faecalis following coccidiostats, in
DSM 32016 accordance with their
respective conditions of
Analytical method(1) authorisation as feed
additives: halofuginone,
Identification: DNA
diclazuril, monensin
sequencing methods or
sodium, robenidine
Pulsed Field Gel
hydrochloride, salinomycin
Electrophoresis (PFGE)
sodium, amprolium, a
– CEN/TS 17697.
combination of monensin
sodium with nicarbazin and
a combination of narasin
and nicarbazin.
6/9
ELI:
http://data.europa.eu/eli/reg_impl/2026/553/oj
EN
OJ
L,
16.3.2026Mini-
Minimum Maximum Maximum mum content content content Identification Name of the Composition, chemical Species or content End of period
Name of the Maximum
number of holder of formula, description, category of Other provisions of
additive age
the additive authorisation analytical method animal CFU/kg of complete authorisation
CFU/l of water for
feed with a moisture
drinking
content of 12 %
Enumeration in the 4. For users of the additive and
feed additive, premixtures, feed business
premixtures, operators shall establish
compound feed and operational procedures and
water for drinking: organisational measures to
Spread plate method on address potential risks
MRS agar (based on EN resulting from their use.
15787 method). Where those risks cannot be
eliminated by such
procedures and measures,
the additive and
premixtures shall be used
with personal breathing and
skin 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.
ELI:
http://data.europa.eu/eli/reg_impl/2026/553/oj
7/9
OJ
L, 16.3.2026
ENPART II
Minimum Maximum
Identification Composition, chemical content content
Name of the holder of Name of the Species or category Maximum End of period of
number of formula, description, Other provisions
authorisation additive of animal age authorisation
the additive analytical method CFU/l of water for
drinking
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1900 Biochem Zusatzstoffe Weizmannia Additive composition All poultry - 5 × 108 - 1. In the directions for use of 1 May 2034
Handels- und faecalisDSM species for the additive, the storage
Preparation of
Produktionsges. mbH 32016 fattening conditions and the
Weizmannia faecalisDSM
stability in water for
32016 containing a
Suckling and drinking shall be
minimum of 2 × 1010
weaned Suidae indicated.
CFU/g additive
piglets
Solid form 2. The additive shall be used
Ornamental via water for drinking.
Characterisation of the birds
active substance 3. The additive may be used
simultaneously with the
Viable spores of
following coccidiostats,
Weizmannia faecalisDSM
in accordance with their
32016
respective conditions of
authorisation as feed
Analytical method(1)
additives: halofuginone,
Identification: DNA diclazuril, monensin
sequencing methods or sodium, robenidine
Pulsed Field Gel hydrochloride,
Electrophoresis (PFGE) – salinomycin sodium,
CEN/TS 17697. amprolium, a
combination of
monensin sodium with
nicarbazin and a
combination of narasin
and nicarbazin.
8/9
ELI:
http://data.europa.eu/eli/reg_impl/2026/553/oj
EN
OJ
L,
16.3.2026Minimum Maximum
Identification Composition, chemical content content Name of the holder of Name of the Species or category Maximum End of period of
number of formula, description, Other provisions
authorisation additive of animal age authorisation
the additive analytical method CFU/l of water for
drinking
Enumeration in the feed 4. For users of the additive
additive, premixtures, and premixtures, feed
compound feed and business operators shall
water for drinking: establish operational
Spread plate method on procedures and
MRS agar (based on EN organisational measures
15787 method). to address potential risks
resulting from their use.
Where those risks cannot
be eliminated by such
procedures and
measures, the additive
and premixtures shall be
used with personal
breathing and skin
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.
ELI:
http://data.europa.eu/eli/reg_impl/2026/553/oj
9/9
OJ
L,
16.3.2026
EN