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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.
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 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 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 .
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
2b11009
—
Trimethylamine
Additive composition
Trimethylamine
Characterisation of the active substance
Trimethylamine
Produced by chemical synthesis
Purity: min. 98 %
Chemical formula: C 3 H 9 N
CAS number: 75-50-3
FLAVIS No: 11.009
Method of analysis
( 1 )
For the determination of trimethylamine in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except laying hens
—
—
—
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 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.
15.3.2028
2b11024
—
Trimethylamine hydrochloride
Additive composition
Trimethylamine hydrochloride
Characterisation of the active substance
Trimethylamine hydrochloride
Produced by chemical synthesis
Purity: min. 98.5 %
Chemical formula: C 3 H 9 N · HCl
CAS number: 593-81-7
FLAVIS No: 11.024
Method of analysis
( 1 )
For the determination of trimethylamine hydrochloride in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except laying hens
—
—
—
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 label of 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.
15.3.2028
2b11001
—
3-Methylbutylamine
Additive composition
3-Methylbutylamine
Characterisation of the active substance
3-Methylbutylamine
Produced by chemical synthesis
Purity: min. 98 %
Chemical formula: C 5 H 13 N
CAS number: 107-85-7
FLAVIS No:11.001
Method of analysis
( 1 )
For the determination of 3-methylbutylamine in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
All animal species except laying hens
—
—
—
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 of complete feedingstuff with a moisture content of 12 % shall be:
—
1 mg/kg for pigs and poultry, except laying hens;
—
1,5 mg/kg for other species and categories.
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, except laying hens;
—
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 label of 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:
—
1 mg/kg for pigs and poultry, except laying hens;
—
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.
15.3.2028
2b03006
—
2-Methoxyethyl benzene
Additive composition
2-Methoxyethyl benzene
Characterisation of the active substance
2-Methoxyethyl benzene
Produced by chemical synthesis
Purity: min. 99 %
Chemical formula: C 9 H 12 O
CAS number: 3558-60-9
FLAVIS No: 03.006
Method of analysis
( 1 )
For the determination of 2-methoxyethyl benzene 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 of complete feedingstuff with a moisture content of 12 % shall be:
—
0,3 mg/kg for pigs and poultry;
—
0,5 mg/kg for other species and categories.
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 label of 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:
—
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
2b04016
—
1,3-Dimethoxy-benzene
Additive composition
1,3-Dimethoxy-benzene
Characterisation of the active substance
1,3-Dimethoxy-benzene
Produced by chemical synthesis
Purity: min. 98 %
Chemical formula: C 8 H 10 O 2
CAS number: 151-10-0
FLAVIS No: 04.016
Method of analysis
( 1 )
For the determination of 1,3-dimethoxy-benzene 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: 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 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: 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
2b04034
—
1,4-Dimethoxy-benzene
Additive composition
1,4-Dimethoxy-benzene
Characterisation of the active substance
1,4-Dimethoxy-benzene
Produced by chemical synthesis
Purity: min. 98 %
Chemical formula: C 8 H 10 O 2
CAS number: 150-78-7
FLAVIS No: 04.034
Method of analysis
( 1 )
For the determination of 1,4-dimethoxy-benzene 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: 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 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: 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
2b04043
—
1-Isopropyl-2-methoxy-4-methylbenzene
Additive composition
1-Isopropyl-2-methoxy-4-methylbenzene
Characterisation of the active substance
1-Isopropyl-2-methoxy-4-methylbenzene
Produced by chemical synthesis
Purity: min. 98 %
Chemical formula: C 11 H 16 O
CAS number: 1076-56-8
FLAVIS No: 04.043
Method of analysis
( 1 )
For the determination of 1-isopropyl-2-methoxy-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: 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 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: 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
Commission Implementing Regulation (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32018R0240
© 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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