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.
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Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (Text with EEA relevance. )
1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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. Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Schedules & Appendices
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 %
Category: Sensory additives. Functional group: Flavouring compounds
2b02015
—
Menthol
Additive composition
Menthol
Characterisation of the active substance
Menthol
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C 10 H 20 O
CAS number: 89-78-1
FLAVIS No: 02.015
Method of analysis
( 1 )
For the determination of menthol 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.
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.’
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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 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 eyes 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.
15.3.2028
2b07146
—
d-Carvone
Additive composition
d-Carvone
Characterisation of the active substance
d-Carvone
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C 10 H 14 O
CAS number: 2244-16-8
FLAVIS No: 07.146
Method of analysis
( 1 )
For the determination of d-carvone 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.
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.’
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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 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 eyes 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.
15.3.2028
2b09016
—
Menthyl acetate
Additive composition
Menthyl acetate
Characterisation of the active substance
Menthyl acetate
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C 12 H 22 O 2
CAS number: 29066-34-0
FLAVIS No: 09.016
Method of analysis
( 1 )
For the determination of menthyl acetate 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.
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.’
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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 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 eyes 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.
15.3.2028
2b07078
—
d,l-Isomenthone
Additive composition
d,l-Isomenthone
Characterisation of the active substance
d,l-Isomenthone
Produced by chemical synthesis
Purity: min. 98 % assay
Chemical formula: C 10 H 18 O
CAS number: 491-07-6
FLAVIS No: 07.078
Method of analysis
( 1 )
For the determination of d,l-isomenthone 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.
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 %:
—
0,3 mg/kg for pigs and poultry;
—
0,5 mg/kg 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
—
0,3 mg/kg for pigs and poultry;
—
0,5 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 eyes 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.
15.3.2028
2b07094
—
3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one
Additive composition
3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one
Characterisation of the active substance
3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one
Produced by chemical synthesis
Purity: min. 98 % assay
Chemical formula: C 11 H 16 O
CAS number: 488-10-8
FLAVIS No: 07.094
Method of analysis
( 1 )
For the determination of 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one 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.
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 %:
—
0,3 mg/kg for pigs and poultry;
—
0,5 mg/kg 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
—
0,3 mg/kg for pigs and poultry;
—
0,5 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 eyes 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.
15.3.2028
2b07126
—
3,5,5-Trimethylcyclohex-2-en-1-one
Additive composition
3,5,5-Trimethylcyclohex-2-en-1-one
Characterisation of the active substance
3,5,5-Trimethylcyclohex-2-en-1-one
Produced by chemical synthesis
Purity: min. 98 % assay
Chemical formula: C 9 H 14 O
CAS number: 78-59-1
FLAVIS No: 07.126
Method of analysis
( 1 )
For the determination of 3,5,5-trimethylcyclohex-2-en-1-one 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.
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 %:
—
0,3 mg/kg for pigs and poultry;
—
0,5 mg/kg 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
—
0,3 mg/kg for pigs and poultry;
—
0,5 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 eyes 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 glove.
15.3.2028
2b07159
—
d-Fenchone
Additive composition
d-Fenchone
Characterisation of the active substance
d-Fenchone
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C 10 H 16 O
CAS number: 4695-62-9
FLAVIS No: 07.159
Method of analysis
( 1 )
For the determination of d-fenchone 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.
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 %:
—
0,3 mg/kg for pigs and poultry;
—
0,5 mg/kg 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
—
0,3 mg/kg for pigs and poultry;
—
0,5 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 eyes 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
15.3.2028
2b02038
—
Fenchyl alcohol
Additive composition
Fenchyl alcohol
Characterisation of the active substance
Fenchyl alcohol
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C 10 H 18 O
CAS number: 1632-73-1
FLAVIS No: 02.038
Method of analysis
( 1 )
For the determination of fenchyl alcohol 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.
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.’
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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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 eyes 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.
15.3.2028
2b09215
—
Carvyl acetate
Additive composition
Carvyl acetate
Characterisation of the active substance
Carvyl acetate
Produced by chemical synthesis
Purity: min. 98 % assay
Chemical formula: C 12 H 18 O 2
CAS number: 97-42-7
FLAVIS No: 09.215
Method of analysis
( 1 )
For the determination of carvyl acetate 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.
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.’
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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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 eyes 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.
15.3.2028
2b09216
—
Dihydrocarvyl acetate
Additive composition
Dihydrocarvyl acetate
Characterisation of the active substance
Dihydrocarvyl acetate
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C 12 H 20 O 2
CAS number: 20777-49-5
FLAVIS No: 09.216
Method of analysis
( 1 )
For the determination of dihydrocarvyl acetate 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.
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.’
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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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 eyes 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.
15.3.2028
2b09269
—
Fenchyl acetate
Additive composition
Fenchyl acetate
Characterisation of the active substance
Fenchyl acetate
Produced by chemical synthesis
Purity: min. 98 % assay
Chemical formula: C 12 H 20 O 2
CAS number: 13851-11-1
FLAVIS No: 09.269
Method of analysis
( 1 )
For the determination of fenchyl acetate 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.
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.’
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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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 eyes 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.
15.3.2028
( 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
Cite this act
Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32018R0245
© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.
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