Commission Implementing Regulation (EU) 2026/171 of 26 January 2026 concerning the renewal of the authorisation of fumaric acid as a feed additive for all terrestrial animal species, repealing Implementing Regulation (EU) No 1078/2013 and amending Implementing Regulation (EU) 2017/56

• CELEX: Implementing Regulation (EU) 2026/171
• Articles: 6

Article 1 Renewal of the authorisation

The authorisation of the substance specified in the Annex, belonging to the additive category ‘technological additives’, functional group ‘preservatives’ and to the additive category ‘sensory additives’, functional group ‘flavouring compounds’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal of Implementing Regulation (EU) No 1078/2013

Implementing Regulation (EU) No 1078/2013 is repealed.

Article 3 Amendment to Implementing Regulation (EU) 2017/56

In the fifth column of the entry 2b08025 of the Annex to Implementing Regulation (EU) 2017/56, the words ‘All animal species’ are replaced by the words ‘Aquatic animal species’.

Article 4 Transitional measures

1.   The feed additive fumaric acid, as authorised by Implementing Regulations (EU) No 1078/2013 and (EU) 2017/56 and premixtures containing that additive, which are intended for terrestrial animal species, and which are produced and labelled before 16 August 2026 in accordance with the rules applicable before 16 February 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 produced and labelled before 16 February 2027 in accordance with the rules applicable before 16 February 2026, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing terrestrial animals.

3.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 16 February 2028 in accordance with the rules applicable before 16 February 2026, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing terrestrial animals.

Article 5 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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed additive

Name of the additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feed with a moisture content of 12 %

Category: technological additives. Functional group: preservatives

1a297

Fumaric acid

Additive composition

Fumaric acid

Solid form

Characterisation of active substance

Fumaric acid ≥ 99,5 %

Produced by chemical synthesis.

C 4 H 4 O 4

CAS No 110-17-8

Analytical method

( 1 )

For the determination of fumaric acid (as total fumaric acid) in the feed additive, premixtures and compound feed:

—

Ion chromatography with conductivity detection (IC-CD) – EN 17294.

Poultry

Pigs other than fed with milk replacers

—

—

20 000

1.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

2.

The simultaneous use of fumaric acid with other sources of fumaric acid is permitted, only if the amount of fumaric acid in feed materials and compound feed is lower than the one resulting from the use of the additive at the maximum or recommended content for the respective animal species or category.

3.

Indicate in the instructions for use of the additive, premixture and related feedingstuffs for food-producing animals: ‘The simultaneous use of different organic acids or their salts is contraindicated, where one or more of them is used at or near the maximum permitted content.’

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures 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 skin, eye and breathing protective equipment.

16 February 2036

Young mammals fed with milk replacers

10 000  ( 2 )

All other terrestrial animal species

—

Identification number of the feed additive

Name of the additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: flavouring compounds

2b08025

Fumaric acid

Additive composition

Fumaric acid

Solid form

Characterisation of active substance

Fumaric acid ≥ 99,5 %

Produced by chemical synthesis

C 4 H 4 O 4

CAS No 110-17-8

FLAVIS No 08.025

Analytical method

( 3 )

For the identification of fumaric acid in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species other than aquatic animal species

—

—

—

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

3.

The simultaneous use of fumaric acid with other sources of fumaric acid is permitted, only if the amount of fumaric acid in feed materials and compound feed is lower than the one resulting from the use of the additive at the maximum or recommended content for the respective animal species or category.

4.

On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures where the use level on the label of the premixture would result in exceeding the level referred to in point 4.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures 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 skin, eye and breathing protective equipment.

16 February 2036

( 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 )   mg of fumaric acid per kg of milk replacer (Dry Matter 94,5 %).

( 3 )   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 .