Commission Implementing Regulation (EU) 2023/255 of 6 February 2023 concerning the renewal of the authorisation of naringin as a feed additive for all animal species and repealing Implementing Regulation (EU) No 870/2012 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/255
• Articles: 5

Article 1 Renewal of the authorisation

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

Article 2 Repeal

Implementing Regulation (EU) No 870/2012 is repealed.

Article 3 Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 27 August 2023 in accordance with the rules applicable before 27 February 2023 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 27 February 2024 in accordance with the rules applicable before 27 February 2023 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 27 February 2025 in accordance with the rules applicable before 27 February 2023 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 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

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: Sensory additives. Functional group: Flavouring compounds

2b16058

Naringin

Additive composition

Naringin

Characterisation of the active substance

Naringin

Extracted from citrus fruits

Purity: ≥ 90 %

(2S)-4H-1-Benzopyran-4-one,7-((2-O-(6- deoxy-alpha-L-mannopyranosyl)-beta-D- glucopyranosyl) oxy)-2,3-dihydro-5- hydroxy-2-(4-hydroxyphenyl)

Chemical formula: C 27 H 32 O 14

CAS number: 10236-47-2

FLAVIS number: 16.058

Analytical method

( 1 )

For the determination of naringin in the feed additive:

—

high performance liquid chromatography (HPLC) method coupled to an UV detector (European Pharmacopeia monograph 2.2.29).

All 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 stability to heat treatment shall be indicated.

3.

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.”

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

27 February 2033

( 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