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.
Transitional measures
1. The feed additive basil tincture from Ocimum basilicum L., as authorised pursuant to Directive 70/524/EEC, and premixtures containing this additive, which are produced and labelled before 13 February 2027 in accordance with the rules applicable before 13 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 13 August 2027 in accordance with the rules applicable before 13 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 13 August 2028 in accordance with the rules applicable before 13 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
2b308-t
Basil tincture
Additive composition
Tincture from dried leaves of Ocimum basilicum L.
Liquid form
Characterisation of active substance
Basil tincture:
Tincture, as defined by the Council of Europe (CoE) ( 1 ) , obtained from the dried leaves of Ocimum basilicum L. by extended extraction with a water/ethanol solvent mixture, pressing and filtration.
EC number: 283-900-8
CAS number: 84775-71-3
CoE number: 308
Specifications
Dry matter content: 1,79 % – 1,8 %
Total polyphenols ( 2 ) : ≤ 0,198 %
Flavonoids ( 3 ) : ≤ 0,0257 %
1,8-Cineole (eucalyptol): ≤ 0,0019 %
Camphor: ≤ 0,0047 %
Rosmarinic acid: ≤ 0,0110 %
Methyleugenol: ≤ 0,0006 %
Estragole: ≤ 0,00005 %
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 1,8-cineole, camphor, estragole and methyleugenol;
—
Gas chromatography coupled with mass spectrometry detection (GC-MS) for the determination of eugenol;
—
High performance liquid chromatography with spectrophotometric (UV) detection for the determination of rosmarinic acid.
Turkeys for fattening
—
—
87
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 basil tincture with other additives is permitted, provided that the contents of methyleugenol and estragole in feed materials and compound feed are lower than those that would result from the use of the additive or the additives with the highest contents of methyleugenol and estragole, among all authorised feed additives, at their 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 skin, eye and breathing protective equipment.
13 August 2036
Chickens for fattening and minor poultry for fattening
—
—
65
All poultry reared for laying or breeding
—
—
97
Ornamental birds
—
—
97
All poultry for laying and breeding
—
—
97
Pigs for fattening
—
—
140
Pigs for fattening of minor Suidae
—
—
140
Piglets (suckling and weaned) of all Suidae
—
—
116
All Suidae for reproduction
—
—
170
Calves for fattening
6 months
—
291
Sheep and goats
—
—
256
Cattle for fattening; other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidae for fattening
—
—
256
All other ruminants;
all other Camelidae
—
—
166
Equidae
—
—
256
Leporidae
—
—
102
Salmonids and minor fin fish
—
—
292
Dogs
—
—
307
Cats
—
—
256
Ornamental fish
—
—
500
Other species and categories
—
—
65
( 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 .