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.
Transitional measures
1. The feed additives juniper essential oil and juniper tincture from Juniperus communis L. as authorised pursuant to Directive 70/524/EEC and premixtures containing those additives, which are produced and labelled before 6 April 2025 in accordance with the rules applicable before 6 October 2024 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 6 October 2025 in accordance with the rules applicable before 6 October 2024 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 6 October 2026 in accordance with the rules applicable before 6 October 2024 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.
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.
ANNEXSupplementary provisions
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 active substance/kg of complete feed with a moisture content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b249-eo
Juniper essential oil
Additive composition
Essential oil from the berries of Juniperus communis L.
Liquid form
Characterisation of the active substance
Juniper essential oil
Essential oil as defined by the Council of Europe ( 1 ) obtained from the berries of Juniperus communis L. by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by decantation.
CAS number: 8002-68-4
FEMA number: 2604
CoE number: 249
Specifications
α-Pinene (pin-2(3)-ene): 25,45 %
β-Pinene (pin-2(10)-ene): 1,12 %
Sabinene (4(10)-thujene): 4,20 %
Myrcene: maximum 3,22 %.
Analytical method
( 2 )
For the determination of the phytochemical marker pin-2(3)-ene in the feed additive (juniper essential oil): gas chromatography coupled with flame ionisation detection (GC-FID) (ISO 8897).
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 the 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 for all poultry for laying or breeding purposes;
—
4 mg for all poultry reared for laying or breeding except turkeys reared for breeding;
—
4 mg for chickens for fattening and minor poultry for fattening;
—
5 mg for turkeys for fattening, and turkeys reared for breeding;
—
3 mg for ornamental birds;
—
10 mg for all Suidae for reproduction;
—
7 mg for piglets (suckling and weaned) of all Suidae;
—
8 mg for pigs for fattening;
—
7 mg for pigs for fattening of minor Suidae;
—
15 mg for:
—
sheep and goats;
—
ruminants and Camelidae for fattening;
—
10 mg for all other ruminants and Camelidae;
—
15 mg for Equidae;
—
17 mg for salmonids and minor fin fish;
—
20 mg for ornamental fish;
—
6 mg for rabbits;
—
18 mg for dogs;
—
3 mg for cats;
—
3 mg for other animal species and categories’.
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 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.
6.10.2034
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 active substance/kg of complete feed with a moisture content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b249-t
Juniper tincture
Additive composition
Tincture from the berries of Juniperus communis L.
Liquid form
Characterisation of the active substance
Juniper tincture
Tincture as defined by the Council of Europe ( 3 ) obtained from the berries of Juniperus communis L. by extraction with a water/ethanol solvent mixture, pressing and filtration.
CoE number: 249
Specifications
Dry matter: maximum 1,5 %
Tannins (as pyrogallol): maximum 0,02 %
α-Pinene: maximum 0,0064 %
Analytical method
( 4 )
For the determination of the phytochemical marker tannins in the feed additive (juniper tincture): spectrophotometry (European Pharmacopoeia monograph 20814).
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 the stability to heat treatment shall be indicated.
3.
On the label of the additive, the following shall be indicated:
‘Recommended content of the active substance per kg of complete feedingstuff, with a moisture content of 12 %: 45 mg for all animal species.’
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 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.
6.10.2034
( 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://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