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.
資料由法律人 LawPlayer整理提供·EU law / curated by LawPlayer from EUR-Lex
Commission Implementing Regulation (EU) 2017/55 of 14 December 2016 concerning the authorisation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate as feed additives for all animal species (Text with EEA relevance. )
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.
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 %
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Category: Sensory additives. Functional group: Flavouring compounds
2b02022
—
Octan-2-ol
Additive composition
Octan-2-ol
Characterisation of the active substance
Octan-2-ol
Produced by chemical synthesis
Purity: min 97 %
C 8 H 18 O
CAS No 123¬96-6
FLAVIS No:02.022
Methods of Analysis
( 1 )
For the determination of octan-2-ol 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 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.
6 February 2027
2b02079
—
Isopropanol
Additive composition
Isopropanol
Characterisation of the active substance
Isopropanol
Produced by chemical synthesis
Purity: min. 99,7 %
Chemical formula: C 3 H 8 O
CAS No 67-63-0
FLAVIS No: 02.079
Method of analysis
( 1 )
For the determination of isopropanol 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:
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 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.
6 February 2027
2b02088
—
Pentan-2-ol
Additive composition
Pentan-2-ol
Characterisation of the active substance
Pentan-2-ol
Produced by chemical synthesis
Purity: min. 97,9 %
Chemical formula: C 5 H 12 O
CAS No 6032-29-7
FLAVIS No: 02.088
Method of analysis
( 1 )
For the determination of pentan-2-ol 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 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.
6 February 2027
2b02098
—
Octan-3-ol
Additive composition
Octan-3-ol
Characterisation of the active substance
Octan-3-ol
Produced by chemical synthesis
Purity: min. 97 %
Chemical formula: C 8 H 18 O
CAS No 589-98-0
FLAVIS No:02.098
Method of analysis
( 1 )
For the determination of octan-3-ol 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 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.
6 February 2027
2b07002
—
Heptan-2-one
Additive composition
Heptan-2-one
Characterisation of the active substance
Heptan-2-one
Produced by chemical synthesis
Purity: min. 95 %
Chemical formula: C 7 H 14 O
CAS No 110-43-0
FLAVIS No: 07.002
Method of analysis
( 1 )
For the determination heptan-2-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.
The recommended maximum content of the active substance shall be:
for piglets: 4 mg/kg, for chickens for fattening and laying hens: 3 mg/kg, for cats: 2 mg/kg and for other species and categories: 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 %:
—
4 mg/kg for piglets;
—
3 mg/kg for chickens for fattening and laying hens;
—
2 mg/kg for cats;
—
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:
—
4 mg/kg for piglets;
—
3 mg/kg for chickens for fattening and laying hens;
—
2 mg/kg for cats;
—
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.
6 February 2027
2b07054
—
Pentan-2-one
Additive composition
Pentan-2-one
Characterisation of the active substance
Pentan-2-one
Produced by chemical synthesis
Purity: min. 95 %
Chemical formula: C 5 H 10 O
CAS No 107-87-9
FLAVIS No: 07.054
Method of analysis
( 1 )
For the determination of pentan-2-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.
The recommended maximum content of the active substance shall be:
for piglets: 4 mg/kg, for chickens for fattening and laying hens: 3 mg/kg, for cats: 2 mg/kg and for other species and categories: 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 %:
—
4 mg/kg for piglets;
—
3 mg/kg for chickens for fattening and laying hens;
—
2 mg/kg for cats;
—
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:
—
4 mg/kg for piglets;
—
3 mg/kg for chickens for fattening and laying hens;
—
2 mg/kg for cats;
—
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.
6 February 2027
2b07099
—
6-Methyl- hepta- 3,5-dien- 2-one
Additive composition
6-Methyl- hepta- 3,5-dien- 2-one
Characterisation of the active substance
6-Methyl- hepta- 3,5-dien- 2-one
Produced by chemical synthesis
Purity: min. 96 %
Chemical formula: C 8 H 12 O
CAS No 1604-28-0
FLAVIS No: 07.099
Method of analysis
( 1 )
For the determination of 6-methyl- hepta- 3,5-dien- 2-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.
The recommended maximum content of the active substance shall be:
for pigs and poultry: 0,3 mg/kg, and for other species and categories: 0,5 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 %:
—
0,3 mg/kg for pigs and poultry;
—
0,5 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:
—
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.
6 February 2027
2b07113
—
Nonan- 3- one
Additive composition
Nonan- 3- one
Characterisation of the active substance
Nonan- 3- one
Produced by chemical synthesis
Purity: min. 95,9 %
Chemical formula: C 9 H 18 O
CAS No 925-78-0
FLAVIS No: 07.113
Method of analysis
( 1 )
For the determination of nonan- 3- 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.
The recommended maximum content of the active substance shall be:
pigs and poultry: 0,3 mg/kg, for fish: 0,05 mg/kg and for other species and categories: 0,5 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 %:
—
0,3 mg/kg for pigs and poultry;
—
0,05 mg/kg for fish;
—
0,5 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:
—
0,3 mg/kg for pigs and poultry;
—
0,05 mg/kg for fish;
—
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.
6 February 2027
2b07150
—
Decan- 2 -one
Additive composition
Decan- 2 -one
Characterisation of the active substance
Decan- 2 -one
Produced by chemical synthesis
Purity: min. 98 %
Chemical formula: C 10 H 20 O
CAS No 693-54-9
FLAVIS No: 07.150
Method of analysis
( 1 )
For the determination of decan- 2 -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.
The recommended maximum content of the active substance shall be:
for pigs and poultry: 0,3 mg/kg, and for other species and categories: 0,5 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 %:
—
0,3 mg/kg for pigs and poultry;
—
0,5 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:
—
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.
6 February 2027
2b09105
—
Isopropyl tetradecanoate
Additive composition
Isopropyl tetradecanoate
Characterisation of the active substance
Isopropyl tetradecanoate
Produced by chemical synthesis
Purity: min. 99 %
Chemical formula: C 17 H 34 O 2
CAS No 110-27-0
FLAVIS No 09.105
Method of analysis
( 1 )
For the determination of isopropyl tetradecanoate 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 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.
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
Cite this act
Commission Implementing Regulation (EU) 2017/55 of 14 December 2016 concerning the authorisation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32017R0055
© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.
本頁資料來源:EUR-Lex·整理提供:法律人 LawPlayer· lawplayer.com