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) 2020/1396 of 5 October 2020 concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals (Text with EEA relevance)
1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 26 April 2021 in accordance with the rules applicable before 26 October 2020 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 specified in the Annex which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 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 specified in the Annex which are produced and labelled before 26 October 2022 in accordance with the rules applicable before 26 October 2020 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
2b02012
-
Geraniol
Additive composition
Geraniol
Characterisation of the active substance
Geraniol
Produced by fractional distillation of an essential oil or by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C 10 H 18 O
CAS number: 106-24-1
FLAVIS No: 02.012
Method of analysis
( 1 )
For the determination of geraniol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b02029
-
3,7,11-Trimethyldodeca-2,6,10-trien-1-ol
Additive composition
3,7,11-Trimethyldodeca-2,6,10-trien-1-ol
Characterisation of the active substance
3,7,11-Trimethyldodeca-2,6,10-trien-1-ol
Produced by chemical synthesis
Purity: min. 96 % assay
Chemical formula: C 15 H 26 O
CAS number: 4602-84-0
FLAVIS No: 02.029
Method of analysis
( 1 )
For the determination of 3,7,11-Trimethyldodeca-2,6,10-trien-1-ol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b02058
-
(Z)-Nerol
Additive composition
(Z)-Nerol
Characterisation of the active substance
(Z)-Nerol
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C 10 H 18 O
CAS number: 106-25-2
FLAVIS No: 02.058
Method of analysis
( 1 )
For the determination of (Z)-nerol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b05020
-
Citral
Additive composition
Citral
Characterisation of the active substance
Citral
Produced by chemical synthesis
Purity: min. 96 % assay
Chemical formula: C 10 H 16 O
CAS number: 5392-40-5
FLAVIS No: 05.020
Method of analysis
( 1 )
For the determination of citral in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09011
-
Geranyl acetate
Additive composition
Geranyl acetate
Characterisation of the active substance
Geranyl acetate
Produced by chemical synthesis
Purity: min. 90 % assay
Chemical formula: C 12 H 20 O 2
CAS number: 105-87-3
FLAVIS No: 09.011
Method of analysis
( 1 )
For the determination of geranyl acetate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09048
-
Geranyl butyrate
Additive composition
Geranyl butyrate
Characterisation of the active substance
Geranyl butyrate
Produced by chemical synthesis
Purity: min. 92 % assay
Chemical formula: C 14 H 24 O 2
CAS number: 106-29-6
FLAVIS No: 09.048
Method of analysis
( 1 )
For the determination of geranyl butyrate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09076
-
Geranyl formate
Additive composition
Geranyl formate
Characterisation of the active substance
Geranyl formate
Produced by chemical synthesis
Purity: min. 94 % assay
Chemical formula: C 11 H 18 O 2
CAS number: 105-86-2
FLAVIS No: 09.076
Method of analysis
( 1 )
For the determination of geranyl formate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09128
-
Geranyl propionate
Additive composition
Geranyl propionate
Characterisation of the active substance
Geranyl propionate
Produced by chemical synthesis
Purity: min. 92 % assay
Chemical formula: C 13 H 22 O 2
CAS number: 105-90-8
FLAVIS No: 09.128
Method of analysis
( 1 )
For the determination of geranyl propionate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09169
-
Neryl propionate
Additive composition
Neryl propionate
Characterisation of the active substance
Neryl propionate
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C 13 H 22 O 2
CAS number: 105-91-9
FLAVIS No: 09.169
Method of analysis
( 1 )
For the determination of neryl propionate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09212
-
Neryl formate
Additive composition
Neryl formate
Characterisation of the active substance
Neryl formate
Produced by chemical synthesis
Purity: min. 90 % assay
Chemical formula: C 11 H 18 O 2
CAS number: 2142-94-1
FLAVIS No: 09.212
Method of analysis
( 1 )
For the determination of neryl formate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09213
-
Neryl acetate
Additive composition
Neryl acetate
Characterisation of the active substance
Neryl acetate
Produced by chemical synthesis
Purity: min. 93 % assay
Chemical formula: C 12 H 20 O 2
CAS number: 141-12-8
FLAVIS No: 09.213
Method of analysis
( 1 )
For the determination of neryl acetate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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.
26.10.2030
2b09424
-
Neryl isobutyrate
Additive composition
Neryl isobutyrate
Characterisation of the active substance
Neryl isobutyrate
Produced by chemical synthesis
Purity: min. 92 % assay
Chemical formula: C 14 H 24 O 2
CAS number: 2345-24-6
FLAVIS No: 09.424
Method of analysis
( 1 )
For the determination of neryl isobutyrate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09431
-
Geranyl isobutyrate
Additive composition
Geranyl isobutyrate
Characterisation of the active substance
Geranyl isobutyrate
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C 14 H 24 O 2
CAS number: 2345-26-8
FLAVIS No: 09.431
Method of analysis
( 1 )
For the determination of geranyl isobutyrate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 label of the premixtures, if the content of the active substance in 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.
26.10.2030
2b09692
-
Prenyl acetate
Additive composition
Prenyl acetate
Characterisation of the active substance
Prenyl acetate
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C 7 H 12 O 2
CAS number: 1191-16-8
FLAVIS No: 09.692
Method of analysis
( 1 )
For the determination of prenyl acetate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except marine animals
-
-
-
1.
The additive shall be incorporated into the feed in the form of a premixture of flavourings.
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 1 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.’
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in 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.
26.10.2030
( 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) 2020/1396 of 5 October 2020 concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32020R1396
© 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