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Commission Implementing Regulation (EU) 2017/54 of 14 December 2016 concerning th... (32017R0054)
EU - Rechtsakte: 03 Agriculture

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)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).
(2) 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, herereinafter referred to as ‘the substances concerned’ were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 October 2012(3) that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that those substances are flavouring agents authorised in food for which the efficacy is demonstrated as the functions of the additive applied for feed use and described for food use are similar.
(5) The Authority concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the Method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. Maximum recommended contents should be set up for those substances. Those substances may be used within a compound feed subsequently administered via water.
(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional 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 3

Entry 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
.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 December 2016.
For the Commission
The President
Jean-Claude JUNCKER
(1)  
OJ L 268, 18.10.2003, p. 29
.
(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (
OJ L 270, 14.12.1970, p. 1
).
(3)  
EFSA Journal
2012;10(10):2927.

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: C4H10O

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: C5H12O

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: C10H22O

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: C8H18O

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: C4H8O

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: C5H10O

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: C5H10O

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: C5H10O2

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: C6H12O2

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: C6H12O2

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: C5H10O2

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: C8H16O2

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: C10H20O2

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: C9H18O2

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: C6H12O2

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: C8H16O2

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: C11H22O2

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: C17H34O2

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: C13H26O2

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: C8H16O2

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: C6H12O2

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: C15H26O6

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: C8H16O2

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: C9H18O2

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: C9H18O2

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: C10H20O2

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: C10H20O2

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: C9H18O2

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
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