Authorisation
The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
Transitional measures
1. The substances as specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks 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 holder of authorisation
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 active substance/kg of complete feedingstuff with a moisture content of 12 %
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Category: Sensory additives. Functional group: Flavouring compounds
2b01002
—
1-Isopropyl-4-methylbenzene
Additive composition
1-Isopropyl-4-methylbenzene
Characterisation of the active substance
1-Isopropyl-4-methylbenzene
Produced by chemical synthesis
Purity: min 97 %
C 10 H 14
CAS No 99¬87-6
FLAVIS No: 01.002
Method of analysis
( 1 )
For the determination of 1-isopropyl-4-methylbenzene in the feed additive and in feed flavouring premixtures:
Gas-chromatography mass spectrometry with retention time locking GC-MS-RTL.
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be:
For cats: 14 mg/kg, and for other species and categories: 25 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:
—
14 mg/kg for cats;
—
25 mg/kg for other species and categories.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:
—
14 mg/kg for cats;
—
25 mg/kg for other species and categories.
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
2b01003
—
Pin-2(10)-ene
Additive composition
Pin-2(10)-ene
Characterisation of the active substance
Pin-2(10)-ene
Produced by chemical synthesis
Purity: min. 97 %
Chemical formula: C 10 H 16
CAS No 127-91-3
FLAVIS No: 01.003
Method of analysis
( 1 )
For the determination of pin-2(10)-ene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
2b01004
—
Pin-2(3)-ene
Additive composition
Pin-2(3)-ene
Characterisation of the active substance
Pin-2(3)-ene
Produced by chemical synthesis
Purity: min. 97 %
Chemical formula: C 10 H 16
CAS No 80-56-8
FLAVIS No: 01.004
Method of analysis
( 1 )
For the determination of pin-2(3)-ene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
2b01007
—
beta-caryophyllene
Additive composition
beta-caryophyllene
Characterisation of the active substance
beta-caryophyllene
Produced by chemical synthesis
Purity: min. 80 %
Chemical formula: C 15 H 24
CAS No 87-44-5
FLAVIS No: 01.007
Method of analysis
( 1 )
For the determination of beta-caryophyllene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
2b01009
—
Camphene
Additive composition
Camphene
Characterisation of the active substance
Camphene
Produced by chemical synthesis
Purity: min. 80 %
Chemical formula: C 10 H 16
CAS No 79-92-5
FLAVIS No: 01.009
Method of analysis
( 1 )
For the determination of camphene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
2b01010
—
1-Isopropenyl-4-methylbenzene
Additive composition
1-Isopropenyl-4-methylbenzene
Characterisation of the active substance
1-Isopropenyl-4-methylbenzene
Produced by chemical synthesis
Purity: min. 97 %
Chemical formula: C 10 H 12
CAS No 1195-32-0
FLAVIS No:01.010
Method of analysis
( 1 )
For the determination of 1-Isopropenyl-4-methylbenzene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be:
for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:
—
1 mg/kg for pigs and poultry;
—
1,5 mg/kg for other species and categories.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:
—
1 mg/kg for pigs and poultry;
—
1,5 mg/kg for other species and categories.
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
2b01029
—
delta-3-Carene
Additive composition
delta-3-Carene
Characterisation of the active substance
delta-3-Carene
Produced by chemical synthesis
Purity: min. 92 %
Chemical formula: C 10 H 16
CAS No 13466-78-9
FLAVIS No:01.029
Method of analysis
( 1 )
For the determination of delta-3-Carene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
2b01045
—
d-Limonene
Additive composition
d-Limonene
Characterisation of the active substance
d-Limonene
Produced by chemical synthesis
Purity: min. 96 %
Chemical formula: C 10 H 16
CAS No 5989-27-5
FLAVIS No: 01.045
Method of analysis
( 1 )
For the determination of d-limonene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except male rats
—
—
—
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 and stability conditions shall be indicated.
3.
The recommended maximum content of the active substance shall be 25 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
6 February 2027
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports