Commission Implementing Regulation (EU) 2025/152 of 29 January 2025 concerning the authorisation of omicha tincture from Schisandra chinensis (Turcz.) Baill. and ginseng tincture from Panax ginseng C.A.Mey. as feed additives for certain animal species

• CELEX: Implementing Regulation (EU) 2025/152
• Articles: 4

Article 1 Authorisation

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

Article 2 Transitional measures

1.   The feed additives omicha tincture from Schisandra chinensis (Turcz.) Baill. and ginseng tincture from Panax ginseng C. A. Mey., as authorised pursuant to Directive 70/524/EEC and premixtures containing these additives, which are produced and labelled before 19 August 2025 in accordance with the rules applicable before 19 February 2025 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 additives referred to in paragraph 1, which are produced and labelled before 19 February 2026 in accordance with the rules applicable before 19 February 2025 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 additives referred to in paragraph 1, which are produced and labelled before 19 February 2027 in accordance with the rules applicable before 19 February 2025 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 3 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 of additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b61281-t

Omicha tincture

Additive composition

Omicha tincture from the fruit of Schisandra chinensis (Turcz.) Baill.

Liquid form

Characterisation of the active substance

Omicha tincture

Tincture as defined by the Council of Europe  ( 1 ) obtained from the dried fruit of Schisandra chinensis (Turcz.) Baill. by extraction with water/ethanol solvent mixture, pressing and filtration.

Specifications

—

Dry matter content: maximum 4 %

—

Sum of schisandrin and deoxyschisandrin: 0,01-0,15 %

Analytical method

( 2 )

For the determination of schisandrin and deoxyschisandrin (phytochemical markers) in the feed additive:

—

high performance liquid chromatography coupled with photometric detection (HPLC-UV)

Dogs

—

—

—

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 %:

—

12 mg for chickens for fattening, minor poultry for fattening and all poultry reared for laying or reared for breeding,

—

18 mg for all poultry species for laying or breeding,

—

16 mg for turkeys for fattening,

—

47 mg for horses and for cats,

—

56 mg for dogs.’.

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 levels on the label of the premixture would result in exceeding the levels 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 by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

19 February 2035

Cats

—

—

—

Horses

—

—

—

Poultry

—

—

—

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

Category: Sensory additives. Functional group: Flavouring compounds

2b318-t

Ginseng tincture

Additive composition

Ginseng tincture from the roots of Panax ginseng C.A.Mey.

Liquid form

Characterisation of the active substance

Ginseng tincture

Tincture as defined by the Council of Europe  ( 3 ) obtained from the roots of Panax ginseng C.A.Mey by extraction with water/ethanol solvent mixture, pressing and filtration.

CoE number: 318

Specifications

—

Dry matter content: maximum: 6 %

—

Sum of ginsenoside Rg1 and ginsenoside Rb1: 0,01-0,5 %

Analytical method

( 4 )

For the determination of ginsenoside-Rg1 and ginsenoside-Rb1 (phytochemical markers) in the feed additive:

—

high performance liquid chromatography coupled with photometric detection (HPLC-UV)

Horses

—

—

—

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 %:

—

48 mg for horses;

—

228 mg for dogs;

—

162 mg for cats.’.

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 levels on the label of the premixture would result in exceeding the levels 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 by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

19 February 2035

Dogs

—

—

—

Cats

—

—

—

( 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

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

( 4 )   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