Date: 2026-03-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2026/534 of 11 March 2026 concerning the authorisation of a preparation of Duddingtonia flagrans NCIMB 30336 as a feed additive for grazing animals of bovine, ovine and caprine species other than for milk production, and for grazing animals of camelids, cervids, equines, porcine species and rabbits (holder of authorisation: International Animal Health Products Pty Ltd, represented in the Union by SynTech Regulatory Europe GmbH)
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
This Commission Implementing Regulation authorises the preparation of *Duddingtonia flagrans* NCIMB 30336 as a feed additive for grazing animals, excluding those for milk production. The authorisation is for zootechnical purposes, specifically to reduce parasitic nematodes on pasture. The regulation entered into force on 11 March 2026, with the end of authorisation set for 1 April 2036.
**Key Points / Main Content**
* **Authorisation of Feed Additive:**
* The preparation of *Duddingtonia flagrans* NCIMB 30336 is authorised as a feed additive for animal nutrition.
* It falls under the category of 'zootechnical additives' and the functional group 'other zootechnical additives'.
* The authorisation is granted to International Animal Health Products Pty Ltd, represented by SynTech Regulatory Europe GmbH.
* **Scope of Application:**
* The additive is authorised for grazing animals of bovine, ovine, and caprine species, but not for those producing milk.
* It is also authorised for grazing animals of camelid, cervid, equine, porcine, and rabbit species.
* The primary purpose is to reduce the number of infective nematode larvae on pasture.
* **Conditions of Use and Safety:**
* The European Food Safety Authority (EFSA) concluded the preparation is safe for the specified animal species, consumers, and the environment under proposed use conditions.
* It is safe for skin and eyes but is an irritant to the respiratory tract and a respiratory sensitiser.
* The minimum dose for use is 3 x 10⁴ chlamydospores/kg bodyweight per day.
* The additive should be used at a minimum dose of 3 × 10⁴ chlamydospores/kg bodyweight and day.
* The additive shall only be used in feed for grazing animals.
* Appropriate protective measures must be taken by users to prevent adverse health effects.
* Storage conditions and stability to heat treatment must be indicated.
* **Specific Details:**
* The minimum and maximum content of chlamydospores/kg of complete feed varies by animal species.
* Analytical methods for identification and enumeration are specified, including DNA-based methods and the yeast mannitol agar method.
* The end of the period of authorisation is 1 April 2036.
**Impact Analysis**
* **Holders of Authorisation (International Animal Health Products Pty Ltd / SynTech Regulatory Europe GmbH)**
* **Impact:** They are granted the authorisation to market and distribute the feed additive.
* **Action Required:** Comply with all specified conditions of use, labelling requirements, and protective measures for users.
* **Feed Business Operators**
* **Impact:** They can now use *Duddingtonia flagrans* NCIMB 30336 as a feed additive for the specified grazing animals.
* **Action Required:** Establish operational procedures and organisational measures to address potential risks from the additive's use, including the use of personal protective equipment if risks cannot be eliminated. Ensure the additive is used only in feed for grazing animals and at the specified dosage.
* **Farmers / Animal Keepers**
* **Impact:** They can administer the authorised feed additive to their grazing livestock, contributing to parasite control on pastures.
* **Action Required:** Use the additive as per the directions provided, ensuring it is mixed into feed for grazing animals at the correct dosage.
* **Consumers**
* **Impact:** The additive is considered safe for consumers.
* **Action Required:** No specific action required, but benefit from the safety assessment.
* **Environment**
* **Impact:** The additive is considered safe for the environment.
* **Action Required:** No specific action required.
* **Users handling the additive (operators)**
* **Impact:** Potential risks of respiratory irritation and sensitisation exist.
* **Action Required:** Implement operational procedures and organisational measures to address potential risks, including the use of personal breathing and skin protective equipment where necessary.
Key Entities Referenced
COMMISSION IMPLEMENTING REGULATION (EU) 2026/534: The primary legal act that authorizes a specific feed additive.
Regulation (EC) No 1831/2003: The overarching EU law governing the authorization of feed additives.
Duddingtonia flagrans NCIMB 30336: The specific feed additive preparation being authorized.
European Food Safety Authority (EFSA): The scientific body that assesses the safety of the feed additive.
Standing Committee on Plants, Animals, Food and Feed: The committee that provides an opinion on the regulation.
Official Journal EN
of the European Union L series
2026/534 12.3.2026
COMMISSION IMPLEMENTING REGULATION(EU) 2026/534
of 11 March 2026
concerning the authorisation of a preparation of Duddingtonia flagransNCIMB 30336 as a feed
additive for grazing animals of bovine, ovine and caprine species other than for milk production, and
for grazing animals of camelids, cervids, equines, porcine species and rabbits (holder of
authorisation: International Animal Health Products Pty Ltd, represented in the Union by SynTech
Regulatory Europe GmbH)
(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 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 Duddingtonia flagrans NCIMB 30336. 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 Duddingtonia flagransNCIMB 30336 as a feed additive
for all grazing animals, requesting that additive to be classified in the category ‘zootechnical additives’, in the
functional group ‘other zootechnical additives’.
(4) Commission Implementing Regulation (EU) 2024/1723(2) authorised the preparation of Duddingtonia flagrans
NCIMB 30336 as a feed additive for grazing animals for milk production of bovine species, sheep, and goats since,
due to the lack of data, the European Food Safety Authority (‘the Authority’) could not conclude on the safety of the
additive for other grazing animal species and categories in its opinions of 2 July 2020(3)and 14 November 2023(4).
(5) Therefore, only the use of that preparation as a feed additive for all grazing animals other than grazing animals for
milk production of bovine species, sheep, and goats remains to be addressed in that application.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Implementing Regulation (EU) 2024/1723 of 20 June 2024 concerning the authorisation of a preparation of
Duddingtonia flagransNCIMB 30336 as a feed additive for grazing animals for milk production of bovine species, sheep and goats
(holder of authorisation: International Animal Health Products Pty Ltd, represented by GAB Consulting GmbH) (OJ L, 2024/1723,
21.6.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1723/oj).
(3) EFSA Journal. 2020;18(7):6208, https://doi.org/10.2903/j.efsa.2020.6208.
(4) EFSA Journal. 2023;21:e8465, https://doi.org/10.2903/j.efsa.2023.8465.
ELI: http://data.europa.eu/eli/reg_impl/2026/534/oj 1/4EN
OJ L, 12.3.2026
(6) The Authority concluded in its opinions of 2 July 2020 and 20 March 2025(5)that, under the proposed conditions
of use, the preparation of Duddingtonia flagrans NCIMB 30336 is safe for all grazing bovines, ovines, caprines,
rabbits, horses, cervids, camelids and porcine species, as well as for consumers and the environment. The Authority
considered that the preparation of Duddingtonia flagransNCIMB 30336 is not irritant to skin and eyes but is irritant
to the respiratory tract and is a respiratory sensitiser, while no conclusion could be drawn on its skin sensitisation
potential. The Authority further concluded that the preparation of Duddingtonia flagransNCIMB 30336 can reduce
the number of parasitic nematodes on pasture to the benefit of grazing animals, when used at the recommended
application rate of 3 × 104chlamydospores/kg body weight and per day. 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.
(7) On 18 June 2025, the applicant withdrew the application for the authorisation of the preparation for all grazing
animals other than bovines, ovines, caprines, camelids, cervids, equines, porcine species and rabbits.
(8) In view of the above, the Commission considers that the preparation of Duddingtonia flagransNCIMB 30336 satisfies
the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of
that preparation should be authorised for grazing animals of bovine, ovine and caprine species other than for milk
production, and for grazing animals of camelid species, cervid species, horses, porcine species and rabbits.
Considering the conclusion of the Authority on the safety of the preparation of Duddingtonia flagransNCIMB 30336
for grazing horses and taking into account that interspecies extrapolation of data can be applied between
physiologically similar species(6), the Commission considers that the authorisation of that preparation should be
extended to grazing equines. In addition, it is appropriate, for practical and control reasons, to express the dosage of
the preparation per kilogram of complete feedingstuff and to provide for the additive to be used only in feed for
grazing animals. Finally, the Commission considers that appropriate protective measures should be taken to prevent
adverse effects on the health of the users of the additive.
(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
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional
group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in
that Annex.
(5) EFSA Journal. 2025;23:e9366, https://doi.org/10.2903/j.efsa.2025.9366.
(6) As set out in the Guidance on the assessment of the safety of feed additives for the target species. EFSA Journal2017;15(10):5021,
https://doi.org/10.2903/j.efsa.2017.5021.
2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/534/ojEN
OJ L, 12.3.2026
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, 11 March 2026.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2026/534/oj 3/4ANNEX
Minimum Maximum
content content
Identification Name of the
Name of the Composition, chemical formula, Species or category Maximum End of period
number of holder of Number of Other provisions
additive description, analytical method of animal age of authorisation
the additive authorisation chlamydospores/kg of
complete feed with a
moisture content of 12 %
Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the number of infective nematode larvae on pasture)
4d27 International Duddingtonia Additive composition Cows for - 8,5 × 105 8,5 × 106 1. In the directions for use of 1 April 2036
Animal Health flagrans reproduction the additive and
Preparation of Duddingtonia
Products Pty NCIMB 30336 and bulls premixtures, the storage
flagransNCIMB 30336,
Ltd, Cows for conditions and stability to
containing a minimum of 5 ×
represented by reproduction heat treatment shall be
105chlamydospores/g
SynTech and bulls of indicated.
additive.
Regulatory minor bovine
Solid form. 2. The additive shall only be
Europe GmbH species
used in feed for grazing
Characterisation of the active
Bovines for - 1,3 × 106 2,6 × 106 animals.
substance
fattening
3. The additive shall be used at
Viable chlamydospores of
Ovines other the minimum dose of 3 × 104
Duddingtonia flagransNCIMB
than dairy sheep chlamydospores/kg
30336
bodyweight and day.
Caprines other
Analytical methods(1)
than dairy goats 4. For users of the additive and
For the identification of premixtures, feed business
Camelids
Duddingtonia flagransNCIMB operators shall establish
30336: DNA based methods. Cervids operational procedures and
For the enumeration of viable organisational measures to
Equines
chlamydospores of address potential risks
Duddingtonia flagransNCIMB resulting from their use.
Calves of bovine - 1,4 × 106 3,0 × 106
30336 in the feed additive, Where those risks cannot be
species
premixtures and compound eliminated by such
feed: the method using yeast Piglets of porcine - 6,0 × 105 1,2 × 106 procedures and measures,
mannitol agar (YMA) with species the additive and premixtures
streptomycin and shall be used with personal
Porcine species - 7,2 × 105 1,4 × 106
chloramphenicol and a most breathing and skin
for fattening
probable number (MPN) for protective equipment.
the enumeration. Sows of porcine - 8,8 × 105 1,7 × 106
species
Rabbits - 5,3 × 105 1,1 × 106
(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.
4/4
ELI:
http://data.europa.eu/eli/reg_impl/2026/534/oj
EN
OJ
L,
12.3.2026