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 such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECnote.
(2)The substances peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L. were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products, 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 peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L. as feed additives for all animal species, requesting the additives 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 substances concerned 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 these additives in water for drinking should not be allowed.
(5)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 24 June 2025note and 25 June 2025note,note, that peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L. are safe at certain maximum concentrations further specified in these opinions for each animal species. The Authority further concluded that the use of peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L. under the proposed conditions is safe for consumers and the environment. The Authority also concluded that peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L. should be considered irritants to skin and eyes, and dermal and respiratory sensitisers, and any exposure is considered a risk. In addition, the Authority concluded that since the leaves of Mentha × piperita L., Thymus serpyllum L., Salvia officinalis L. and preparations thereof are recognised to flavour food and their 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 additives 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 peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L. satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives.
(7)The Commission considers that safety reasons do not require the setting of maximum levels for peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L.. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additives. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances 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.
(9)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 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 2Transitional measures#
1.The feed additives peppermint tincture from Mentha × piperita L., wild thyme tincture from Thymus serpyllum L. and sage tincture from Salvia officinalis L., as authorised pursuant to Directive 70/524/EEC, and premixtures containing these additives, 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 additives 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 additives 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 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 of additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 2b282-t | Peppermint tincture | Additive compositionTincture from dried leaves or aerial parts of Mentha × piperita L. (basionym: Mentha aquatica × Mentha spicata L.)Liquid formCharacterisation of active substancePeppermint tincture:Tincture, as defined by the Council of Europe (CoE)note, obtained from the dried leaves or the aerial parts of Mentha × piperita L. by extended extraction with a water/ethanol solvent mixture, pressing and filtration.EC number: 282-015-4CAS number: 84082-70-2CoE number: 282SpecificationsDry matter content: 1,84 % – 1,85 %Total polyphenolsnote: ≤ 0,1020 %Flavonoidsnote: ≤ 0,0261 %Menthol: ≤ 0,0021 %Menthone: ≤ 0,0010 %Rosmarinic acid: ≤ 0,00099 %Analytical methodnoteFor the characterisation of the feed additive:Spectrophotometry for the determination of total polyphenols and total flavonoids;Gas chromatography coupled with flame ionisation detection (GC-FID) for the determination of menthol and menthone;High performance liquid chromatography with spectrophotometric (UV) detection for the determination of rosmarinic acid. | 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 feed with a moisture content of 12 %:86 mg for turkeys for fattening;64 mg for chickens for fattening and minor poultry for fattening;64 mg for all poultry reared for laying or breeding;64 mg for ornamental birds;95 mg all poultry for laying or breeding;138 mg for pigs for fattening;115 mg for piglets (suckling and weaned) of all Suidae;115 mg for pigs for fattening of minor Suidae;168 mg for all Suidae for reproduction;287 mg for calves for fattening up to 6 months;253 mg for sheep and goats;253 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidae for fattening;164 mg for all other ruminants and all other Camelidae;253 mg for Equidae;101 mg for Leporidae;289 mg for salmonids and minor fin fish;303 mg for dogs;253 mg for cats;500 mg for ornamental fish;64 mg for other 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 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 skin, eye and breathing 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 additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 2b455-t | Wild thyme tincture | Additive compositionTincture from dried leaves or aerial parts of Thymus serpyllum L.Liquid formCharacterisation of active substanceWild thyme tincture:Tincture, as defined by the Council of Europe (CoE)note, obtained from the dried leaves or the aerial parts of Thymus serpyllum L. by extended extraction with a water/ethanol solvent mixture, pressing and filtration.EC number: 284-023-3CAS number: 84776-98-7CoE number: 455SpecificationsDry matter content: 1 %Total polyphenolsnote: ≤ 0,0923 %Flavonoidsnote: ≤ 0,02338 %Thymol: ≤ 0,000020 %Carvacrol: ≤ 0,000043 %Rosmarinic acid: ≤ 0,00107 %Analytical methodnoteFor the characterisation of the feed additive:Spectrophotometry for the determination of total polyphenols and total flavonoids;Gas chromatography coupled with flame ionisation detection (GC-FID) for the determination of thymol and carvacrol;High performance liquid chromatography with spectrophotometric (UV) detection for the determination of rosmarinic acid. | 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 feed with a moisture content of 12 %:96 mg for turkeys for fattening;71 mg for chickens for fattening and minor poultry for fattening;71 mg for all poultry reared for laying or breeding;71 mg for ornamental birds;106 mg all poultry for laying or breeding;154 mg for pigs for fattening;128 mg for piglets (suckling and weaned) of all Suidae;128 mg for pigs for fattening of minor Suidae;187 mg for all Suidae for reproduction;321 mg for calves for fattening up to 6 months;282 mg for sheep and goats;282 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidae for fattening;183 mg for all other ruminants and all other Camelidae;282 mg for Equidae;113 mg for Leporidae;322 mg for salmonids and minor fin fish;338 mg for dogs;282 mg for cats;500 mg for ornamental fish;71 mg for other 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 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 skin, eye and breathing 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 additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 2b414-t | Sage tincture | Additive compositionTincture from dried leaves of Salvia officinalis L.Liquid formCharacterisation of active substanceSage tincture:Tincture, as defined by the Council of Europe (CoE)note, obtained from the dried leaves of Salvia officinalis L. by extended extraction with a water/ethanol solvent mixture, pressing and filtration.EC number: 282-025-9CAS number: 84082-79-1CoE number: 414SpecificationsDry matter content: 1,75 % – 1,78 %Total polyphenolsnote: ≤ 0,328 %Flavonoidsnote: ≤ 0,0482 %Thujones: ≤ 0,0132 %Camphor: ≤ 0,0130 %1,8-Cineole (eucalyptol): ≤ 0,0070 %Rosmarinic acid: ≤ 0,0662 %Analytical methodnoteFor the characterisation of the feed additive:Spectrophotometry for the determination of total polyphenols and total flavonoids;Gas chromatography coupled with flame ionisation detection (GC-FID) for the determination of thujones, camphor and 1,8-cineole;High performance liquid chromatography with spectrophotometric (UV) detection for the determination of rosmarinic acid. | 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 feed with a moisture content of 12 %:47 mg for turkeys for fattening;35 mg for chickens for fattening and minor poultry for fattening;35 mg for all poultry reared for laying or breeding;35 mg for ornamental birds;52 mg all poultry for laying or breeding;75 mg for pigs for fattening;62 mg for piglets (suckling and weaned) of all Suidae;62 mg for pigs for fattening of minor Suidae;91 mg for all Suidae for reproduction;156 mg for calves for fattening up to 6 months;137 mg for sheep and goats;137 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidae for fattening;89 mg for all other ruminants and all other Camelidae;137 mg for Equidae;55 mg for Leporidae;156 mg for salmonids and minor fin fish;164 mg for dogs;137 mg for cats;500 mg for ornamental fish;35 mg for other 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 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 skin, eye and breathing protective equipment. | 16 August 2036 |
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