Contents
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 2003 on additives for use in animal nutritionnote, 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 and renewing such an authorisation.
(2)Eugenol produced by chemical synthesis or by the extraction from cloves or cloves oil and 1-methoxy-4-(prop-1(trans)-enyl)benzene, which is a synonym for trans-anethole, produced by chemical synthesis or by the extraction from pine oil, were authorised for a period of 10 years as feed additives for all animal species except poultry and fish by Commission Implementing Regulation (EU) 2022/1452note.
(3)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of eugenol produced by the extraction from dried clove leaves or clove leaf oil and for the authorisation of trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4)The application concerns the authorisation of eugenol produced by the extraction from dried clove leaves or clove leaf oil and of trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise as feed additives for poultry and ornamental birds, requesting those additives to be classified in the category ‘sensory additives’ and in the functional group ‘flavouring compounds.’
(5)However, the Commission considers that the application for the authorisation of trans-anethole produced by chemical synthesis for ornamental birds should be treated as an application for the renewal of the authorisation granted by Implementing Regulation (EU) 2022/1452, as that authorisation concerned the same additive and included the use for ornamental birds. In addition, the Commission considers that trans-anethole produced from pine oil authorised for ornamental birds by Implementing Regulation (EU) 2022/1452 should be authorised with a maximum content as it has the same specifications in terms of composition as the trans-anethole produced by chemical synthesis that is going to be renewed with a maximum content due to the zootechnical effects of this additive for those species. The maximum content will prevent an increase of the zootechnical effects beyond the desired flavouring effect pursued in this authorisation.
(6)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 March 2025note that, under the proposed conditions of use, eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise are safe for poultry species for fattening (chickens and turkeys) at 25 mg/kg complete feed and are very unlikely to induce adverse effects in long-living and reproductive birds (poultry reared for laying/breeding, laying/breeding hens and ornamental birds) up to 25 mg/kg complete feed. These conclusions can be extrapolated to physiologically-related minor species. The Authority also concluded that eugenol and trans-anethole are safe for consumers and the environment. It also concluded that when handling eugenol produced by extraction from dried clove leaves or clove leaf oil and trans-anethole produced by extraction from leaves or fruit of star anise, exposure of unprotected users to methyleugenol and estragole, respectively, may occur, and that therefore, to reduce the risk, the exposure of the users should be minimised. In addition, the Authority concluded that eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise are not irritant to skin but are dermal and respiratory sensitisers, that eugenol produced by the extraction from dried clove leaves or clove leaf oil is an eye irritant, but trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise is not, and that any exposure to these additives is considered a risk. The Authority further concluded that since eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary. The Authority did not consider that there is a need for specific requirements of post-market monitoring.
(7)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additives and verified by the Authority in its opinion of 15 November 2011note, are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005note, an evaluation report by the Reference Laboratory was therefore not required.
(8)In view of the above, the Commission considers that eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of eugenol produced by the extraction from dried clove leaves or clove leaf oil should be authorised for poultry and ornamental birds, the use of trans-anethole produced by chemical synthesis should be authorised for poultry and should be renewed for ornamental birds and the use of trans-anethole produced by the extraction from leaves or fruit of star anise should be authorised for poultry and ornamental birds.
(9)Eugenol and trans-anethole are already authorised as zootechnical additives by Commission Implementing Regulation (EU) 2019/898note and Commission Implementing Regulation (EU) 2017/420note, respectively to produce zootechnical effects in poultry at levels of use of 5 mg/kg for eugenol and 7,5 mg/kg for trans-anethole. Since ornamental birds are species physiologically related to poultry the same effects are expected in them. In order to prevent the use of the additives for poultry and ornamental birds at higher levels which could potentially increase the zootechnical effects, beyond the desired flavouring effect pursued in this authorisation, it is necessary to establish a maximum content of the additives in complete feed. In addition, the Commission considers that the presence of methyleugenol in eugenol produced by the extraction from dried clove leaves or clove leaf oil and of estragole in trans-anethole produced by the extraction from leaves or fruit of star anise requires the setting of maximum content in complete feed and that a simultaneous use of eugenol or trans-anethole with other additives is permitted provided that the content of methyleugenol or estragole in feed materials and compound feed remains below that which would result from using the additive with the highest content of methyleugenol or estragole, among all authorised feed additives, at their maximum or recommended content for the relevant species or animal category. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.
(10)As regards trans-anethole, the characterisation of the active substance differs between the additive produced by chemical synthesis and the additive produced by the extraction from leaves or fruit of star anise, with the latter possibly containing estragole. It is therefore appropriate to differentiate between the terms of their authorisation accordingly. In addition, for reasons of clarity and consistency, it is appropriate to reflect the similar differentiation into the existing authorisation of trans-anethole between the additive produced by the extraction from pine oil and the additive produced by chemical synthesis. This differentiation should further allow to remove the use for ornamental birds as regards trans-anethole produced by chemical synthesis as a consequence of the renewal of the authorisation of the additive for ornamental birds and to set a maximum content for ornamental birds for trans-anethole produced from pine oil. Implementing Regulation (EU) 2022/1452 should therefore be amended accordingly.
(11)In addition, to simplify the labelling of trans-anethole and of feed containing it, the Commission considers appropriate to use the name of the additive ‘trans-anethole’ instead of the synonym ‘1-methoxy-4-(prop-1(trans)-enyl)benzene’, which was referred to in Implementing Regulation (EU) 2022/1452. That Implementing Regulation should therefore be amended accordingly.
(12)Since safety reasons do not require the immediate application of the modifications to the conditions of the authorisation of trans-anethole it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from those modifications.
(13)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 1Authorisation#
The substances specified in Annex I, 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 2Renewal of the authorisation#
The authorisation of the substance specified in Annex II, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds,’ is renewed subject to the conditions laid down in that Annex.
Article 3Amendment to Implementing Regulation (EU) 2022/1452#
The Annex to Implementing Regulation (EU) 2022/1452 is amended in accordance with Annex III to this Regulation.
Article 4Transitional measures#
1.The feed additive 1-methoxy-4-(prop-1(trans)-enyl)benzene (synonym trans-anethole), as authorised by Implementing Regulation (EU) 2022/1452, and premixtures containing that additive, which are produced and labelled before 16 February 2027 in accordance with the rules applicable before 16 August 2026 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 additive referred to in paragraph 1, which are produced and labelled before 16 August 2027 in accordance with the rules applicable before 16 August 2026 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 additive referred to in paragraph 1, which are produced and labelled before 16 August 2028 in accordance with the rules applicable before 16 August 2026 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 5Entry 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.
Annex I
| Identification number of the additive | Name of the 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 the active substance/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: sensory additives. Functional group: flavouring compounds | ||||||||
| 2b04003i | Eugenol | Additive compositionEugenolCharacterisation of the active substanceEugenolProduced by the extraction from dried clove leaves or clove leaf oil (Eugenia caryophyllata Thunberg) by steam distillation.Purity: > 98 %Chemical formula: C10H12O2CAS number: 97-53-0FLAVIS: 04.003Methyleugenol ≤ 0,02 %Analytical methodnoteFor the identification of eugenol in the feed additive and in feed flavouring premixtures:Gas-chromatography mass spectrometry with retention time locking (GC-MS-RTL) | Poultry and ornamental birds | — | — | 25 | 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. Simultaneous use of eugenol (2b04003i) with the additive 4d18 is not permitted.4. Simultaneous use of eugenol (2b04003i) with other additives, except the additive mentioned in point 3, is permitted provided that the content of methyleugenol in feed materials and compound feed is lower than that which would result from the use of the additive with the highest content of methyleugenol, among all authorised feed additives, at its maximum or recommended content for the relevant species or animal category.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 breathing, eye and skin protective equipment. | 16 August 2036 |
| Identification number of the additive | Name of the 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 the active substance/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: sensory additives. Functional group: flavouring compounds | ||||||||
| 2b04010 | Trans-anethole | Additive compositionTrans-anetholenoteCharacterisation of the active substanceTrans-anetholeProduced by chemical synthesisPurity: > 99 %Chemical formula: C10H12OCAS number: 4180-23-8FLAVIS: 04.010Analytical methodnoteFor the identification of trans-anethole in the feed additive and in feed flavouring premixtures:Gas-chromatography mass spectrometry with retention time locking (GC-MS-RTL) | Poultry | — | — | 25 | 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. 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 breathing, eye and skin protective equipment. | 16 August 2036 |
| Identification number of the additive | Name of the 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 the active substance/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: sensory additives. Functional group: flavouring compounds | ||||||||
| 2b04010i | Trans-anethole | Additive compositionTrans-anetholenoteCharacterisation of the active substanceTrans-anetholeProduced by the extraction from leaves or fruit of star anise (Illicium verum Hook.f) by steam distillation.Purity: > 99 %Chemical formula: C10H12OCAS number: 4180-23-8FLAVIS: 04.010Estragole ≤ 0,08 %Analytical methodnoteFor the identification of trans-anethole in the feed additive and in feed flavouring premixtures:Gas-chromatography mass spectrometry with retention time locking (GC-MS-RTL) | Poultry and ornamental birds | — | — | 25 | 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. Simultaneous use of trans-anethole (2b04010i) with other additives is permitted provided that the content of estragole in feed materials and compound feed is lower than that which would result from the use of the additive with the highest content of estragole, among all authorised feed additives, at its maximum or recommended content for the relevant species or animal category.4. 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 breathing, eye and skin protective equipment. | 16 August 2036 |
Annex II
| Identification number of the additive | Name of the 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 the active substance/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: sensory additives. Functional group: flavouring compounds | ||||||||
| 2b04010 | Trans-anethole | Additive compositionTrans-anetholenoteCharacterisation of the active substanceTrans-anetholeProduced by chemical synthesis Purity: > 99 %Chemical formula: C10H12OCAS number: 4180-23-8FLAVIS: 04.010Analytical methodnoteFor the identification of trans-anethole in the feed additive and in feed flavouring premixtures:Gas-chromatography mass spectrometry with retention time locking (GC-MS-RTL) | Ornamental birds | — | 25 | 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. 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 breathing, eye and skin protective equipment. | 16 August 2036 |
III
In the Annex to Implementing Regulation (EU) 2022/1452 the entry for the additive with the identification number 2b04010 is replaced by the following:
notenoteIdentification number of the additiveName of the additiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg of the active substance/kg of complete feed with a moisture content of 12 %Category: sensory additives. Functional group: flavouring compounds‘2b04010Trans-anetholeAdditive compositionTrans-anetholenoteCharacterisation of the active substanceTrans-anetholeProduced by the extraction of pine oilPurity: > 99 %Chemical formula: C10H12OCAS number: 4180-23-8FLAVIS: 04.010Analytical methodnoteFor the identification of trans-anethole in the feed additive and in feed flavouring premixtures:Gas-chromatography mass spectrometry with retention time locking (GC-MS-RTL)All animal species except poultry, ornamental birds and fish———
1.The additive shall be incorporated into the feed in the form of a premixture.
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.
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 %:
—all animal species except poultry, ornamental birds and fish: 25 mg.’
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 %:
—all animal species except poultry, ornamental birds and fish: 25 mg.’
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.
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 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.
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 breathing, eye and skin protective equipment.
22 September 2032Ornamental birds——25notenoteIdentification number of the additiveName of the additiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg of the active substance/kg of complete feed with a moisture content of 12 %Category: sensory additives. Functional group: flavouring compounds2b04010Trans-anetholeAdditive compositionTrans-anetholenoteCharacterisation of the active substanceTrans-anetholeProduced by chemical synthesisPurity: > 99 %Chemical formula: C10H12OCAS number: 4180-23-8FLAVIS: 04.010Analytical methodnoteFor the identification of trans-anethole in the feed additive and in feed flavouring premixtures:Gas-chromatography mass spectrometry with retention time locking (GC-MS-RTL)All animal species except poultry, ornamental birds and fish———22 September 2032
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