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.
Transitional 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.
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.
ANNEXSupplementary provisions
ANNEX
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 composition
Tincture from dried leaves or aerial parts of Mentha × piperita L. (basionym: Mentha aquatica × Mentha spicata L.)
Liquid form
Characterisation of active substance
Peppermint tincture:
Tincture, as defined by the Council of Europe (CoE) ( 1 ) , 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: 282-015-4
CAS number: 84082-70-2
CoE number: 282
Specifications
Dry matter content: 1,84 % – 1,85 %
Total polyphenols ( 2 ) : ≤ 0,1020 %
Flavonoids ( 3 ) : ≤ 0,0261 %
Menthol: ≤ 0,0021 %
Menthone: ≤ 0,0010 %
Rosmarinic acid: ≤ 0,00099 %
Analytical method
( 4 )
For 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
( 1 ) Natural sources of flavourings – Report No 2 (2007).
( 2 ) Expressed as gallic acid equivalents (GAE).
( 3 ) Expressed as hyperoside equivalents.
( 4 ) 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
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 composition
Tincture from dried leaves or aerial parts of Thymus serpyllum L.
Liquid form
Characterisation of active substance
Wild thyme tincture:
Tincture, as defined by the Council of Europe (CoE) ( 5 ) , 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: 284-023-3
CAS number: 84776-98-7
CoE number: 455
Specifications
Dry matter content: 1 %
Total polyphenols ( 6 ) : ≤ 0,0923 %
Flavonoids ( 7 ) : ≤ 0,02338 %
Thymol: ≤ 0,000020 %
Carvacrol: ≤ 0,000043 %
Rosmarinic acid: ≤ 0,00107 %
Analytical method
( 8 )
For 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
( 5 ) Natural sources of flavourings – Report No 2 (2007).
( 6 ) Expressed as gallic acid equivalents (GAE).
( 7 ) Expressed as hyperoside equivalents.
( 8 ) 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
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 composition
Tincture from dried leaves of Salvia officinalis L.
Liquid form
Characterisation of active substance
Sage tincture:
Tincture, as defined by the Council of Europe (CoE) ( 9 ) , obtained from the dried leaves of Salvia officinalis L. by extended extraction with a water/ethanol solvent mixture, pressing and filtration.
EC number: 282-025-9
CAS number: 84082-79-1
CoE number: 414
Specifications
Dry matter content: 1,75 % – 1,78 %
Total polyphenols ( 10 ) : ≤ 0,328 %
Flavonoids ( 11 ) : ≤ 0,0482 %
Thujones: ≤ 0,0132 %
Camphor: ≤ 0,0130 %
1,8-Cineole (eucalyptol): ≤ 0,0070 %
Rosmarinic acid: ≤ 0,0662 %
Analytical method
( 12 )
For 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
( 9 ) Natural sources of flavourings – Report No 2 (2007).
( 10 ) Expressed as gallic acid equivalents (GAE).
( 11 ) Expressed as hyperoside equivalents.
( 12 ) 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 .