Commission Implementing Regulation (EU) 2026/2076 of 17 September 2026 concerning the authorisation of nutmeg essential oil from Myristica fragrans Houtt. as a feed additive for all animal species

Official Journal EN of the European Union L series 2026/2076 18.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2076 of 17 September 2026 concerning the authorisation of nutmeg essential oil from Myristica fragransHoutt. as a feed additive for all 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 2003 on 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 an 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 substance nutmeg essential oil from Myristica fragransHoutt. 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 nutmeg essential oil from Myristica fragrans Houtt. 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 12 May 2023(3) that nutmeg essential oil from Myristica fragransHoutt. is considered to be of no safety concern for target short-living animals and very unlikely to induce adverse effects for long-living and reproductive animals and any other animal species at certain maximum concentrations, further specified in that opinion for each animal species. Furthermore, it concluded that no concern for consumer safety was identified from the use of nutmeg essential oil from Myristica fragrans Houtt., up to the highest proposed use level in feed. The Authority concluded that the use of nutmeg essential oil from Myristica fragrans Houtt. under the proposed conditions is not expected to pose a risk to the environment and that nutmeg essential oil from Myristica fragransHoutt. should be considered as an irritant to skin and eyes, and as a skin and respiratory sensitiser. It also stated that, based on the presence of safrole ≥ 0,1 %, nutmeg essential oil from Myristica fragransHoutt. is classified as carcinogen (category 1B) and exposure by any route should be minimised. The Authority further concluded that since nutmeg essential oil from Myristica fragrans Houtt. 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.

(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 Journal2023, 21(6): 8066, https://doi.org/10.2903/j.efsa.2023.8066.

ELI: http://data.europa.eu/eli/reg_impl/2026/2076/oj 1/5EN OJ L, 18.9.2026

(6) In view of the above, the Commission considers that nutmeg essential oil from Myristica fragransHoutt. 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 myristicin, safrole, elemicin and methyelugenol, substances of concern belonging to p-allylalkoxybenzenes group, in nutmeg essential oil from Myristica fragransHoutt. requires the setting of a maximum content for this feed additive in complete feed. Furthermore, the Commission considers that the simultaneous use of nutmeg essential oil from Myristica fragransHoutt. with other feed additives is permitted provided that the combined content of p-allylalkoxy­ benzenes (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 1 Authorisation 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 2 Transitional measures

1. The feed additive nutmeg essential oil from Myristica fragransHoutt., as authorised pursuant to Directive 70/524/EEC and premixtures containing this additive, which are produced and labelled before 8 April 2027 in accordance with the rules applicable before 8 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 8 October 2027 in accordance with the rules applicable before 8 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 8 October 2028 in accordance with the rules applicable before 8 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.

2/5 ELI: http://data.europa.eu/eli/reg_impl/2026/2076/ojEN OJ L, 18.9.2026 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, 17 September 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/2076/oj 3/5ANNEX Minimum Maximum content content Identification Name of Composition, chemical formula, description, Species or category of Maximum End of period of number of the Other provisions analytical method. animal age mg active substance/kg authorisation the additive additive of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b296-eo Nutmeg Additive composition Turkeys for — — 3,7 1. The additive shall be 8 October 2036 essential Essential oil from the seeds of Myristica fattening incorporated into the feed in oil fragransHoutt. the form of a premixture.

Chickens for — — 2,8 Liquid form fattening and minor poultry for 2. In the directions for use of Characterisation of the active substance fattening the additive and premixtures, the storage

Nutmeg essential oil: All poultry reared — — 0,2 conditions and the stability for laying or Essential oil, as defined by the Council of to heat treatment shall be breeding Europe(1), obtained from the dried and indicated.

crushed seeds of Myristica fragransHoutt.

Ornamental birds — — 0,2 by steam distillation and further

3. Simultaneous use of condensation of volatile constituents and All poultry for — — 0,2 nutmeg essential oil with separation from the aqueous phase by laying or breeding other feed additives is decantation.

Pigs for fattening — — 6,0 permitted provided that the

CAS number: 8008-45-5(2) combined content of p-

Einecs number: 282-013-3(2) Pigs for fattening — — 5,0 allylalkoxybenzenes

FEMA number: 2793 of minor Suidae (methyleugenol, estragole,

CoE number: 296 elemicin, safrole, myristicin, Piglets (suckling — — 0,2 dillapiole, and apiole) in feed

Specifications: and weaned) of all materials and compound Suidae

Sabinene: 14-29 % feed remains below the α-Pinene (pin-2(3)-ene): 15-28 % All Suidaefor — — 0,3 content that would result β-Pinene (pin-2(10)-ene): 13-18 % reproduction from using the authorised 4-Terpinenol: 2-6 % feed additive with the Calves for fattening 6 months — 10

Limonene: 2-7 % highest content of those γ – Terpinene: 2-6 % Sheep and goats — — 10 substances at its maximum Myristicin. maximum 12 % for fattening or recommended

Safrole: maximum 2,3 % maximum content for the

Elemicin: maximum 0,4 % Other sheep and — — 0,5 relevant animal species or

Methyleugenol: maximum 0,33 % goats category.

4/5

ELI:

http://data.europa.eu/eli/reg_impl/2026/2076/oj EN OJ L,

18.9.2026Minimum Maximum content content Identification Name of Composition, chemical formula, description, Species or category of Maximum End of period of number of the Other provisions analytical method. animal age mg active substance/kg authorisation the additive additive of complete feed with a moisture content of 12 % Analytical method(3) Cattle for fattening; — — 10 4. For users of the additive and For the determination of pin-2(3)-ene other ruminants premixtures, feed business (phytochemical marker) in the feed for fattening except operators shall establish

additive: sheep, goats and operational procedures and calves for fattening organisational measures to gas-chromatography coupled with flame up to 6 months address potential risks ionisation detection (GC-FID) (ISO 3215). old; Camelidaefor resulting from their use.

fattening Where those risks cannot be eliminated by such All other — — 0,3 procedures and measures, ruminants; the additive and all other Camelidae premixtures shall be used with personal skin, eye and Equidae — — 0,5 breathing protective Leporidaefor — — 4,4 equipment.

fattening Other Leporidae — — 0,2 Salmonids and — — 10 minor fin fish Dogs — — 0,6 Cats — — 0,5 Ornamental fish — — 2,5 Other species and — — 0,2 categories

(1) Natural sources of flavourings – Report No 2 (2007).

(2) Here it only refers to the essential oil from the seeds of Myristica fragransHoutt.

(3) 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/2026/2076/oj 5/5 OJ L,

18.9.2026 EN