Commission Implementing Regulation (EU) 2015/1103 of 8 July 2015 concerning the authorisation of beta-carotene as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1103
• Articles: 4

Article 1

The substance 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 authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 29 January 2016 in accordance with the rules applicable before 29 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 29 July 2016 in accordance with the rules applicable before 29 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 29 July 2017 in accordance with the rules applicable before 29 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

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 holder of authorisation

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, provitamins and chemically well defined substances having a similar effect

3a160(a)

Beta-carotene

Additive composition

Beta-carotene.

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 fermentation or chemical synthesis.

Strains used in the fermentation:

Blakeslea trispora Thaxter slant XCPA 07-05-1 (CGMCC  ( 1 ) 7.44) and XCPA 07-05-2 (CGMCC 7.45).

Purity criteria:

—

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

—

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

Method of Analysis

( 2 )

For the determination of Beta- carotene in the feed additive: spectrophotometric method based on the European Pharmacopoeia (Ph. Eur. monograph 1069).

For the determination of Beta-carotene in premixtures and feedingstuffs: Reverse Phase High Performance Liquid Chromatography (RP-HPLC) coupled to UV detector.

All animal species

—

—

1.

Beta-carotene may be placed on the market and used as an additive consisting of a preparation.

2.

In milk replacers for calves it is recommended a maximum content of 50 mg of beta-carotene/kg of milk replacer.

3.

In the directions for use of the additive and premixture, indicate storage and stability conditions.

4.

For safety: breathing protection shall be worn during handling.

29 July 2025

( 1 )   China General Microbiological Culture Collection Centre.

( 2 )   Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports