Commission Implementing Regulation (EU) 2015/264 of 18 February 2015 concerning the authorisation of neohesperidine dihydrochalcone as a feed additive for sheep, fish, dogs, calves and certain categories of pigs Text with EEA relevance

• CELEX: Implementing Regulation (EU) 2015/264
• Articles: 4

Article 1

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘Flavourings compounds’, is authorised as additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 11 September 2015 in accordance with the rules applicable before 11 March 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for pigs, calves sheep and dogs.

Compound feed, feed materials containing that substance which are produced and labelled before 11 September 2015 in accordance with the rules applicable before 11 March 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for pigs, calves and sheep.

Compound feed and feed materials containing that substance which are produced and labelled before 11 March 2017 in accordance with the rules applicable before 11 March 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for dogs.

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/kg of complete feedingstuff with a moisture content of 12 %.

Category: Sensory additives. Functional group: Flavouring compounds

2b959

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Neohesperidine dihydrochalcone

Additive composition

Neohesperidine dihydrochalcone

Ethanol ≤ 5 000 mg/kg

Characterisation of the active substance

Neohesperidine dihydrochalcone

C 28 H 36 O 15

CAS No: 20702-77-6

Neohesperidine dihydrochalcone, solid form, produced by chemical synthesis

Purity: min. 96 % (dried basis)

Method of analysis

( 1 )

For the determination of neohesperidine dihydrochalcone in the feed additive: Thin Layer Chromatography (TLC), European Pharmacopoeia 6,0, method 01/2008:1547.

For the determination of neohesperidine dihydrochalcone in premixtures and feedingstuffs: High-Performance Liquid Chromatography with Diode-Array Detection (HPLC-DAD).

Piglets and pigs for fattening.

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1.

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

2.

For safety: breathing protection, safety glasses and gloves should be worn during handling.

11 March 2025

Calves

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35

Sheep

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35

Fish

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35

Dogs

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