Commission Implementing Regulation (EU) 2024/824 of 8 March 2024 concerning the authorisation of gentian tincture from Gentiana lutea L. as a feed additive for certain animal species

• CELEX: Implementing Regulation (EU) 2024/824
• Articles: 6

Article 1 Authorisation

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

Article 2 Withdrawal from the market

The feed additive gentian tincture from Gentiana lutea L., as authorised pursuant to Directive 70/524/EEC, shall be withdrawn from the market in respect of the animal species and categories other than those mentioned in the Annex.

Article 3 Transitional measures related to the authorisation

1.   The feed additive referred to in Article 2 and premixtures containing that additive, which are produced and labelled before 30 September 2024 in accordance with the rules applicable before 31 March 2024, may continue to be placed on the market and used in respect of the animal species and categories mentioned in the Annex until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in Article 2, which are produced and labelled before 31 March 2025 in accordance with the rules applicable before 31 March 2024, may continue to be placed on the market and used in respect of the animal species and categories mentioned in the Annex until the stocks concerned are exhausted.

Article 4 Transitional measures related to the withdrawal from the market

1.   Existing stocks of the feed additive referred to in Article 2 may continue to be placed on the market and used in respect of the animal species and categories other than those mentioned in the Annex until 31 March 2025.

2.   Premixtures produced with the feed additive referred to in paragraph 1 may continue to be placed on the market and used in respect of the animal species and categories other than those mentioned in the Annex until 30 June 2025.

3.   Compound feed and feed materials produced with the feed additive referred to in paragraph 1 or with the premixtures referred to in paragraph 2 may continue to be placed on the market and used in respect of the animal species and categories other than those mentioned in the Annex until 31 March 2026.

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

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

Category: sensory additives. Functional group: flavouring compounds

2b2506-t

Gentian tincture

Additive composition

Tincture from roots of Gentiana lutea L.

Liquid form

Characterisation of the active substance

Tincture obtained from the roots of Gentiana lutea L. by extended extraction with a water/ethanol mixture as defined the Council of Europe  ( 1 ) .

FEMA number: 2506

Specifications

Dry matter: 3,5-5 %

Total polyphenols: 0,05-0,11 %

Total flavonoids:0,03-0,06 %

Xanthones: maximum 0,004 %

—

Gentisin

—

Isogentisin

Gentiopicroside: maximum 0,006 %

Analytical method

( 2 )

For the identification and characterisation of the feed additive:

—

Gravimetry for the determination of dry matter and ash content;

—

Spectrophotometry for the determination of total polyphenols content; and

—

High performance thin-layer chromatography (HPTLC) for the determination of contents of total flavonoids, xanthones (gentisin and isogentisin) and gentiopicroside.

Pigs for fattening and pigs for fattening of minor Suidae

Cattle for fattening, sheep for fattening, minor ruminants for fattening and calves for fattening

Chickens for fattening, turkeys for fattening and minor poultry for fattening

Salmonids and minor finfish except brood stock

Other minor species for fattening except Equidae

—

—

50

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.

This additive shall not be used in combination with other additives containing gentisin, isogentisin and gentiopicroside.

4.

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

31 March 2034

( 1 )   Natural sources of flavourings – Report No 2 (2007).

( 2 )   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