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Official Journal EN
of the European Union L series
2025/152 30.1.2025
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).
(2) The substances omicha tincture from Schisandra chinensis (Turcz.) Baill and ginseng tincture from Panax ginseng
C.A.Mey. were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all
animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products,
in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the authorisation of omicha tincture from Schisandra chinensis (Turcz.) Baill. and
ginseng tincture from Panax ginseng C.A.Mey. as feed additives for all animal species, requesting the additives to be
classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The
application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC)
No 1831/2003.
(4) The applicant subsequently withdrew the application for authorisation of omicha tincture from Schisandra chinensis
(Turcz.) Baill. as regards the use for all animal species except horses, dogs, cats, poultry, and for authorisation of
ginseng tincture from Panax ginseng C.A.Mey. as regards the use for all animal species except horses, cats and dogs.
(5) The applicant requested the substances concerned to be authorised for use also in water for drinking. However,
Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for
drinking. Therefore, the use of these additives in water for drinking should not be allowed.
(6) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 12 March 2024(3)and 13 March
2024(4) that omicha tincture from Schisandra chinensis (Turcz.) Baill. is safe for horses, dogs, cats, poultry and
consumers at certain maximum concentrations further specified for each species and that ginseng tincture from
Panax ginseng C.A.Mey. is safe for horses, dogs, cats and consumers at the proposed use level in feed. It also found
that the use of omicha tincture from Schisandra chinensis (Turcz.) Baill and ginseng tincture from Panax ginseng
C.A.Mey. in animal feed, is not considered to pose a risk to the environment. The Authority concluded that omicha
tincture from Schisandra chinensis (Turcz.) Baill. and ginseng tincture from Panax ginseng C.A.Mey should be
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http://
data.europa.eu/eli/dir/1970/524/oj).
(3) EFSA Journal. 2024;22:e8730.
(4) EFSA Journal. 2024;22:e8731.
ELI: http://data.europa.eu/eli/reg_impl/2025/152/oj 1/7EN
OJ L, 30.1.2025
considered as irritants to skin and eyes, and as skin and respiratory sensitisers. The Authority further concluded that
since the fruit of Schisandra chinensis (Turcz.) Baill can influence sensory properties of feedingstuffs, and since the
roots of Panax ginseng C.A.Mey. and their preparations and extracts are recognised to flavour food and their
function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered
necessary. It also verified the report on the method of analysis of the feed additives in feed submitted by the
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(7) In view of the above, the Commission considers that omicha tincture from Schisandra chinensis (Turcz.) Baill. and
ginseng tincture from Panax ginseng C.A.Mey. satisfy the conditions, as provided for in Article 5 of Regulation (EC)
No 1831/2003. Accordingly, the use of those substances should be authorised as specified in the Annex to this
Regulation. In addition, the Commission considers that appropriate protective measures should be taken to prevent
adverse effects on the health of the users of the additives.
(8) The Commission considers that safety reasons do not require the setting of maximum levels for omicha tincture
from Schisandra chinensis (Turcz.) Baill and ginseng tincture from Panax ginseng C.A.Mey. In order to allow better
control, the recommended maximum content should be indicated on the label of the feed additives. Where the
recommended maximum content is exceeded, certain information should be indicated on the label of the
premixtures concerned.
(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare
themselves to meet the new requirements resulting from the authorisation.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
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 2025in accordance with the rules applicable before 19 February 2025may 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.
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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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 January 2025.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2025/152/oj 3/7ANNEX
Minimum Maximum
content content
Identification Species or Maxi-
Composition, chemical formula, description, End of period of
number of the Additive category of mum Other provisions
analytical method mg of additive/kg of complete authorisation
feed additive animal age
feedingstuff with a moisture
content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b61281-t Omicha Additive composition Dogs — — — 1. The additive shall be 19 February
tincture incorporated into the feed in 2035
Omicha tincture from the fruit of
the form of a premixture.
Schisandra chinensis (Turcz.) Baill.
Cats — — —
2. In the directions for use of
Liquid form
the additive and
premixtures, the storage
Characterisation of the active substance
Horses — — — conditions and stability to
heat treatment shall be
Omicha tincture
indicated.
Poultry — — —
Tincture as defined by the Council of
3. On the label of the additive,
Europe(1)obtained from the dried fruit of
the following shall be
Schisandra chinensis (Turcz.) Baill. by
indicated: ‘Recommended
extraction with water/ethanol solvent
maximum content of the
mixture, pressing and filtration.
active substance per kg of
complete feedingstuff with a
Specifications moisture content of 12 %:
— 12 mg for chickens for
— Dry matter content: maximum 4 % fattening, minor poultry
— Sum of schisandrin and for fattening and all
deoxyschisandrin: 0,01-0,15 % poultry reared for laying
or reared for breeding,
Analytical method(2) — 18 mg for all poultry
species for laying or
For the determination of schisandrin and
breeding,
deoxyschisandrin (phytochemical
markers) in the feed additive:
— high performance liquid
chromatography coupled with
photometric detection (HPLC-UV)
4/7
ELI:
http://data.europa.eu/eli/reg_impl/2025/152/oj
EN
OJ
L,
30.1.2025Minimum Maximum
content content Identification Species or Maxi-
Composition, chemical formula, description, End of period of
number of the Additive category of mum Other provisions
analytical method mg of additive/kg of complete authorisation
feed additive animal age
feedingstuff with a moisture
content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
— 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.
(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
ELI:
http://data.europa.eu/eli/reg_impl/2025/152/oj
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ENMinimum Maximum
Identifica-
content content
tion Species or
Composition, chemical formula, description, Maximum End of period of
number of Additive category Other provisions
analytical method age mg of additive/kg of complete authorisation
the feed of animal
feedingstuff with a moisture
additive
content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b318-t Ginseng Additive composition Horses — — — 1. The additive shall be 19 February
tincture incorporated into the feed in 2035
Ginseng tincture from the roots of Panax Dogs — — —
the form of a premixture.
ginseng C.A.Mey.
Cats — — —
2. In the directions for use of
Liquid form
the additive and
premixtures, the storage
Characterisation of the active substance
conditions and stability to
heat treatment shall be
Ginseng tincture
indicated.
Tincture as defined by the Council of
3. On the label of the additive,
Europe(1)obtained from the roots of Panax
the following shall be
ginseng C.A.Mey by extraction with water/
indicated: ‘Recommended
ethanol solvent mixture, pressing and
maximum content of the
filtration.
active substance per kg of
complete feedingstuff with a
CoE number: 318 moisture content of 12 %:
Specifications
— Dry matter content: maximum: 6 %
— Sum of ginsenoside Rg1 and
ginsenoside Rb1: 0,01-0,5 %
6/7
ELI:
http://data.europa.eu/eli/reg_impl/2025/152/oj
EN
OJ
L,
30.1.2025Minimum Maximum
Identifica-
content content tion Species or
Composition, chemical formula, description, Maximum End of period of
number of Additive category Other provisions
analytical method age mg of additive/kg of complete authorisation
the feed of animal
feedingstuff with a moisture
additive
content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
Analytical method(2) — 48 mg for horses;
— 228 mg for dogs;
For the determination of ginsenoside-Rg1
— 162 mg for cats.’.
and ginsenoside-Rb1 (phytochemical
markers) in the feed additive:
4. The functional group, the
— high performance liquid
identification number, the
chromatography coupled with
name and the added amount
photometric detection (HPLC-UV)
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.
(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
ELI:
http://data.europa.eu/eli/reg_impl/2025/152/oj
7/7
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