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Regulation

Commission Implementing Regulation (EU) 2017/54 of 14 December 2016 concerning the authorisation of 2-methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate as feed additives for all animal species (Text with EEA relevance. )

CELEX
Implementing Regulation (EU) 2017/54
Date of document
Articles
4
Source
EUR-Lex
Article 1Authorisation

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.

Article 2Transitional measures

1.   The substances 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 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 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.

Article 3Entry 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 .

Schedules & Appendices

ANNEX

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

2b02001

2-Methylpropan-1-ol

Additive composition

2-Methylpropan-1-ol

Characterisation of the active substance

2-Methylpropan-1-ol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 4 H 10 O

CAS number 78-83-1

FLAVIS 02.001

Method of analysis

( 1 )

For the determination of 2-Methylpropan-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

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02003

Isopentanol

Additive composition

Isopentanol

Characterisation of the active substance

Isopentanol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 5 H 12 O

CAS number 123-51-3

FLAVIS 02.003

Method of analysis

( 1 )

For the determination of Isopentanol 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b02026

3,7-Dimethyloctan-1-ol

Additive composition

3,7-Dimethyloctan-1-ol

Characterisation of the active substance

3,7-Dimethyloctan-1-ol

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C 10 H 22 O

CAS number 106-21-8

FLAVIS 02.026

Method of analysis

( 1 )

For the identification of 3,7-Dimethyloctan-1-ol in the feed additive and 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b02082

2-Ethylhexan-1-ol

Additive composition

2-Ethylhexan-1-ol

Characterisation of the active substance

2-Ethylhexan-1-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C 8 H 18 O

CAS number 104-76-7

FLAVIS 02.082

Method of analysis

( 1 )

For the determination of 2-Ethylhexan-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

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b05004

2-Methylpropanal

Additive composition

2-Methylpropanal

Characterisation of the active substance

2-Methylpropanal

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 4 H 8 O

CAS number 78-84-2

FLAVIS 05.004

Method of analysis

( 1 )

For the determination of 2-Methylpropanal 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05006

3-Methylbutanal

Additive composition

3-Methylbutanal

Characterisation of the active substance

3-Methylbutanal

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 5 H 10 O

CAS number 590-86-3

FLAVIS 05.006

Method of analysis

( 1 )

For the determination of 3-Methylbutanal 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b05049

2-Methylbutyraldehyde

Additive composition

2-Methylbutyraldehyde

Characterisation of the active substance

2-Methylbutyraldehyde

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C 5 H 10 O

CAS number 96-17-3

FLAVIS 05.049

Method of analysis

( 1 )

For the determination of 2-Methylbutyraldehyde 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08008

3-Methylbutyric acid

Additive composition

3-Methylbutyric acid

Characterisation of the active substance

3-Methylbutyric acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C 5 H 10 O 2

CAS number 503-74-2

FLAVIS 08.008

Method of analysis

( 1 )

For the determination of 3-Methylbutyric acid 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08031

2-Methylvaleric acid

Additive composition

2-Methylvaleric acid

Characterisation of the active substance

2-Methylvaleric acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 6 H 12 O 2

CAS number 97-61-0

FLAVIS 08.031

Method of analysis

( 1 )

For the determination of 2-Methylvaleric acid 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08045

2-Ethylbutyric acid

Additive composition

2-Ethylbutyric acid

Characterisation of the active substance

2-Ethylbutyric acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 6 H 12 O 2

CAS number 88-09-5

FLAVIS 08.045

Method of analysis

( 1 )

For the determination of 2-Ethylbutyric acid 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08046

2-Methylbutyric acid

Additive composition

2-Methylbutyric acid

Characterisation of the active substance

2-Methylbutyric acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 5 H 10 O 2

CAS number 116-53-0

FLAVIS 08.046

Method of analysis

( 1 )

For the determination of 2-Methylbutyric acid 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08047

2-Methylheptanoic acid

Additive composition

2-Methylheptanoic acid

Characterisation of the active substance

2-Methylheptanoic acid

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C 8 H 16 O 2

CAS number 1188-02-9

FLAVIS 08.047

Method of analysis

( 1 )

For the determination of 2-Methylheptanoic acid 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08062

4-Methylnonanoic acid

Additive composition

4-Methylnonanoic acid

Characterisation of the active substance

4-Methylnonanoic acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 10 H 20 O 2

CAS number 45019-28-1

FLAVIS 08.062

Method of analysis

( 1 )

For the identification of 4-Methylnonanoic acid in the feed additive and 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08063

4-Methyloctanoic acid

Additive composition

4-Methyloctanoic acid

Characterisation of the active substance

4-Methyloctanoic acid

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C 9 H 18 O 2

CAS number 54947-74-9

FLAVIS 08.063

Method of analysis

( 1 )

For the determination of 4-Methyloctanoic acid 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09005

Isobutyl acetate

Additive composition

Isobutyl acetate

Characterisation of the active substance

Isobutyl acetate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 6 H 12 O 2

CAS number 110-19-0

FLAVIS 09.005

Method of analysis

( 1 )

For the determination of Isobutyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09043

Isobutyl butyrate

Additive composition

Isobutyl butyrate

Characterisation of the active substance

Isobutyl butyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 8 H 16 O 2

CAS number 539-90-2

FLAVIS 09.043

Method of analysis

( 1 )

For the determination of Isobutyl butyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09070

3-Methylbutyl hexanoate

Additive composition

3-Methylbutyl hexanoate

Characterisation of the active substance

3-Methylbutyl hexanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 11 H 22 O 2

CAS number 2198-61-0

FLAVIS 09.070

Method of analysis

( 1 )

For the identification of 3-Methylbutyl hexanoate in the feed additive and 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09103

3-Methylbutyl dodecanoate

Additive composition

3-Methylbutyl dodecanoate

Characterisation of the active substance

3-Methylbutyl dodecanoate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C 17 H 34 O 2

CAS number 6309-51-9

FLAVIS 09.103

Method of analysis

( 1 )

For the identification of 3-Methylbutyl dodecanoate in the feed additive and 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09120

3-Methylbutyl octanoate

Additive composition

3-Methylbutyl octanoate

Characterisation of the active substance

3-Methylbutyl octanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 13 H 26 O 2

CAS number 2035-99-6

FLAVIS 09.120

Method of analysis

( 1 )

For the identification of 3-Methylbutyl octanoate in the feed additive and 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09136

3-Methylbutyl propionate

Additive composition

3-Methylbutyl propionate

Characterisation of the active substance

3-Methylbutyl propionate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 8 H 16 O 2

CAS number 105-68-0

FLAVIS 09.136

Method of analysis

( 1 )

For the determination of 3-Methylbutyl propionate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09162

3-Methylbutyl formate

Additive composition

3-Methylbutyl formate

Characterisation of the active substance

3-Methylbutyl formate

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C 6 H 12 O 2

CAS number 110-45-2

FLAVIS 09.162

Method of analysis

( 1 )

For the determination of 3-Methylbutyl formate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09211

Glyceryl tributyrate

Additive composition

Glyceryl tributyrate

Characterisation of the active substance

Glyceryl tributyrate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C 15 H 26 O 6

CAS number 60-01-5

FLAVIS 09.211

Method of analysis

( 1 )

For the determination of Glyceryl tributyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09417

Isobutyl isobutyrate

Additive composition

Isobutyl isobutyrate

Characterisation of the active substance

Isobutyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 8 H 16 O 2

CAS number 97-85-8

FLAVIS 09.417

Method of analysis

( 1 )

For the determination of Isobutyl isobutyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09419

Isopentyl isobutyrate

Additive composition

Isopentyl isobutyrate

Characterisation of the active substance

Isopentyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 9 H 18 O 2

CAS number 2050-01-3

FLAVIS 09.419

Method of analysis

( 1 )

For the determination of Isopentyl isobutyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09472

Isobutyl isovalerate

Additive composition

Isobutyl isovalerate

Characterisation of the active substance

Isobutyl isovalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 9 H 18 O 2

CAS number 589-59-3

FLAVIS 09.472

Method of analysis

( 1 )

For the determination of Isobutyl isovalerate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09530

Isopentyl 2-methylbutyrate

Additive composition

Isopentyl 2-methylbutyrate

Characterisation of the active substance

Isopentyl 2-methylbutyrate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 10 H 20 O 2

CAS number 27625-35-0

FLAVIS 09.530

Method of analysis

( 1 )

For the determination of Isopentyl 2-methylbutyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09531

2-Methylbutyl isovalerate

Additive composition

2-Methylbutyl isovalerate

Characterisation of the active substance

2-Methylbutyl isovalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 10 H 20 O 2

CAS number 2445-77-4

FLAVIS 09.531

Method of analysis

( 1 )

For the determination of 2-Methylbutyl isovalerate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09659

2-Methylbutyl butyrate

Additive composition

2-Methylbutyl butyrate

Characterisation of the active substance

2-Methylbutyl butyrate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 9 H 18 O 2

CAS number 51115-64-1

FLAVIS 09.659

Method of analysis

( 1 )

For the determination of 2-Methylbutyl butyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

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

4 articles

Cite this act

Commission Implementing Regulation (EU) 2017/54 of 14 December 2016 concerning the authorisation of 2-methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32017R0054

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

EU-EurLex-Reuse-2011-833

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