Commission Implementing Regulation (EU) 2026/2090

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 nutrition^note, 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 an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC^note.

(2)The substance star anise essential oil, previously identified as anise star oil, from Illicium verum Hook.f. was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This substance was subsequently entered in the Register of Feed Additives as an existing product, 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 star anise essential oil from Illicium verum Hook.f. as a feed additive for all animal species, requesting the additive 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 requested the additive to be authorised also for use 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 this additive in water for drinking should not be allowed.

(5)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2023^note that, under the proposed conditions of use, star anise essential oil from Illicium verum Hook.f. is considered of no safety concern for target short-living animals and is considered very unlikely to induce adverse effects for target long-living and reproductive animals and for any other animal species at certain maximum concentrations. Furthermore, it concluded that no safety concern would be expected for consumers from the use of star anise essential oil from Illicium verum Hook.f., up to the highest proposed use level in feed, and that its use, under the proposed conditions, is not expected to pose a risk to the environment. The Authority concluded that star anise essential oil from Illicium verum Hook.f. should be considered as irritant to skin and eyes, as skin and respiratory sensitiser. It also stated that, based on the presence of estragole (≥ 1 %), star anise essential oil from Illicium verum Hook.f. is classified as suspected of causing genetic defects and of causing cancer and exposure by any route should be minimised. The Authority further concluded that since star anise essential oil from Illicium verum Hook.f. is recognised to flavour food and its 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)In view of the above, the Commission considers that star anise essential oil from Illicium verum Hook.f. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. The Commission considers that the presence of estragole (substance of concern belonging to a group of p-allylalkoxybenzenes, compounds which are genotoxic and carcinogenic) requires the setting of maximum content for this feed additive in complete feed. Furthermore, the Commission considers that a simultaneous use of star anise essential oil from Illicium verum Hook.f. with other feed additives is permitted provided that the combined content of p-allylalkoxybenzenes (methyleugenol, estragole, elemicin, safrole, myristicin, dillapiole, and apiole) in feed materials and compound feed remains below the content that would result from using the authorised feed additive with the highest content of those substances at its maximum or recommended maximum content for the relevant animal species or 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.

(7)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance 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.

(8)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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2Transitional measures#

1.The feed additive star anise essential oil from Illicium verum Hook.f., as authorised pursuant to Directive 70/524/EEC and premixtures containing this additive, which are produced and labelled before 11 April 2027 in accordance with the rules applicable before 11 October 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 11 October 2027 in accordance with the rules applicable before 11 October 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 11 October 2028 in accordance with the rules applicable before 11 October 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 3Entry 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.

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 active substance/kg of complete feed with a moisture content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b238-eo	Star anise essential oil	Additive compositionEssential oil from the dry fruit of Illicium verum Hook.f.Liquid formCharacterisation of the active substanceStar anise essential oil:Essential oil, as defined the Council of Europe^note, obtained from the dry fruit (without or with the presence of plant leaves) of Illicium verum Hook.f. by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by decantation.CAS numbers: 84650-59-9^noteand 68952-43-2Einecs number: 283-518-1^noteFEMA number: 2096CoE number:238Specificationstrans-Anethole(1-methoxy-4-(prop-1(trans)-enyl)benzene): 85-93 %Estragole: maximum 6 %Limonene: 0,2-6 %Linalool: 0,2-2,5 %Safrole: maximum 0,01 %Analytical method^noteFor the determination of trans-anethole (phytochemical marker) in the feed additive:Gas chromatography coupled to flame ionisation detection (GC-FID) ISO 11016.	Turkeys for fattening	—	—	24,8	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. Simultaneous use of star anise essential oil with other feed additives is permitted provided that the combined content of p-allylalkoxybenzenes (methyleugenol, estragole, elemicin, safrole, myristicin, dillapiole, and apiole) in feed materials and compound feed remains below the content that would result from using the authorised feed additive with the highest content of those substances at its maximum or recommended maximum content for the relevant animal species or category.4. 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.	11 October 2036
Chickens for fattening and minor poultry for fattening	—	—	18,5
All poultry reared for laying or breeding	—	—	0,6
Ornamental birds	—	—	0,6
All poultry for laying or breeding	—	—	0,6
Pigs for fattening	—	—	40,0
Pigs for fattening of minor Suidae	—	—	33,3
Piglets (suckling and weaned) of all Suidae	—	—	0,6
All Suidae for reproduction	—	—	1,0
Calves for fattening	6 months	—	83,3
Sheep and goats for fattening	—	—	73,3
Other sheep and goats	—	—	1,6
Cattle for fattening; other ruminants for fattening except sheep, goats and calves for fattening up to 6 months old; Camelidae for fattening	—	—	73,3
All other ruminants;all other Camelidae	—	—	1,0
Equidae	—	—	1,6
Leporidae for fattening	—	—	29,3
Other Leporidae	—	—	0,6
Salmonids and minor fin fish	—	—	83,8
Dogs	—	—	1,9
Cats	—	—	1,6
Ornamental fish	—	—	6,5
Other species and categories	—	—	0,6