Commission Implementing Regulation (EU) 2026/1148 of 28 May 2026 concerning the renewal of the authorisation of beta-carotene and a preparation of beta-carotene as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/1103

• CELEX: Implementing Regulation (EU) 2026/1148
• Articles: 5

Article 1 Renewal of the Authorisation

The authorisation of the substance and the preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal

Implementing Regulation (EU) 2015/1103 is repealed.

Article 3 Transitional measures

1.   The feed additive beta-carotene, as authorised by Implementing Regulation (EU) 2015/1103, and premixtures containing that additive, which are intended for all animal species and which are produced and labelled before 18 December 2026 in accordance with the rules applicable before 18 June 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 18 June 2027 in accordance with the rules applicable before 18 June 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 18 June 2028 in accordance with the rules applicable before 18 June 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 animals.

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 .

Schedules & Appendices

ANNEX

ANNEX

Identification number of the 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 active substance/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

3a160

Beta-carotene

Additive composition

Beta-carotene

Solid form

Triphenylphosphine oxide (TPPO)

≤ 100 mg/kg of the additive.

Characterisation of the active substance

Beta-carotene

C 40 H 56

CAS number: 7235-40-7

Beta-carotene, solid form, produced by chemical synthesis.

Purity criteria :

—

(assay) min. 96 % total colouring matters (dried substance) expressed as beta-carotene,

—

carotenoids other than beta-carotene: ≤ 3 % of total colouring matters.

Analytical method

( 1 )

For the determination of beta-carotene in the feed additive:

—

Spectrophotometry – Food Chemical Codex ‘β-Carotene monograph’.

For the determination of beta-carotene in premixtures and compound feed:

—

Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550.

Calves (milk replacers)

—

—

50

1.

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

18 June 2036

Other animal species and categories

—

—

—

( 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 .

Identification number of the 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

3a160i

Beta-carotene

Additive composition

Preparation of beta-carotene with a minimum of 10 % of beta-carotene.

Solid form

Triphenylphosphine oxide (TPPO)

≤ 100 mg/kg of the additive.

Characterisation of the active substance

Beta-carotene

C 40 H 56

CAS number: 7235-40-7

Beta-carotene, solid form, produced by chemical synthesis.

Purity criteria :

—

(assay) min. 96 % total colouring matters (dried substance) expressed as beta-carotene,

—

carotenoids other than beta-carotene: ≤ 3 % of total colouring matters.

Analytical method

( 2 )

For the determination of beta-carotene in the feed additive:

—

Spectrophotometry.

For the determination of beta-carotene in premixtures and compound feed:

—

Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550.

Calves (milk replacers)

—

—

50

1.

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

2.

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 appropriate personal protective equipment, including eyes, skin and breathing protection.

18 June 2036

Other animal species and categories

—

—

—

( 2 )   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 .