LegalizeCommission Implementing Regulation (EU) 2024/2414 of 13 September 2024 concerning the authorisation of juniper essential oil and juniper tincture from Juniperus communis L. as feed additives for all animal species
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
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.
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.
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.
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.
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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | mg active substance/kg of complete feed with a moisture content of 12 % | mg active substance/kg of complete feed with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | ||||||
| 2b249-eo | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | 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 [^E0001]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 [^E0002] 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). | Other provisions | End of period of authorisation | 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 |
Natural sources of flavourings – Report No 2 (2007).
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
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | mg active substance/kg of complete feed with a moisture content of 12 % | mg active substance/kg of complete feed with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | ||||||
| 2b249-t | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | 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 [^E0003]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 [^E0004] For the determination of the phytochemical marker tannins in the feed additive (juniper tincture): spectrophotometry (European Pharmacopoeia monograph 20814). | Other provisions | End of period of authorisation | 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 |
Natural sources of flavourings – Report No 2 (2007).
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
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