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Regulation

Commission Implementing Regulation (EU) 2017/55 of 14 December 2016 concerning the authorisation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate as feed additives for all animal species (Text with EEA relevance. )

CELEX
Implementing Regulation (EU) 2017/55
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 as specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

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

2b02022

Octan-2-ol

Additive composition

Octan-2-ol

Characterisation of the active substance

Octan-2-ol

Produced by chemical synthesis

Purity: min 97 %

C 8 H 18 O

CAS No 123¬96-6

FLAVIS No:02.022

Methods of Analysis

( 1 )

For the determination of octan-2-ol in the feed additive and in feed flavouring premixtures:

Gas-chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

1 mg/kg for pigs and poultry;

1,5 mg/kg for other species and categories.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

1 mg/kg for pigs and poultry;

1,5 mg/kg for other species and categories.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b02079

Isopropanol

Additive composition

Isopropanol

Characterisation of the active substance

Isopropanol

Produced by chemical synthesis

Purity: min. 99,7 %

Chemical formula: C 3 H 8 O

CAS No 67-63-0

FLAVIS No: 02.079

Method of analysis

( 1 )

For the determination of isopropanol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

25 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b02088

Pentan-2-ol

Additive composition

Pentan-2-ol

Characterisation of the active substance

Pentan-2-ol

Produced by chemical synthesis

Purity: min. 97,9 %

Chemical formula: C 5 H 12 O

CAS No 6032-29-7

FLAVIS No: 02.088

Method of analysis

( 1 )

For the determination of pentan-2-ol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

1 mg/kg for pigs and poultry;

1,5 mg/kg for other species and categories.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

1 mg/kg for pigs and poultry;

1,5 mg/kg for other species and categories.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b02098

Octan-3-ol

Additive composition

Octan-3-ol

Characterisation of the active substance

Octan-3-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C 8 H 18 O

CAS No 589-98-0

FLAVIS No:02.098

Method of analysis

( 1 )

For the determination of octan-3-ol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

1 mg/kg for pigs and poultry;

1,5 mg/kg for other species and categories.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

1 mg/kg for pigs and poultry;

1,5 mg/kg for other species and categories.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b07002

Heptan-2-one

Additive composition

Heptan-2-one

Characterisation of the active substance

Heptan-2-one

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 7 H 14 O

CAS No 110-43-0

FLAVIS No: 07.002

Method of analysis

( 1 )

For the determination heptan-2-one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

for piglets: 4 mg/kg, for chickens for fattening and laying hens: 3 mg/kg, for cats: 2 mg/kg and for other species and categories: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

4 mg/kg for piglets;

3 mg/kg for chickens for fattening and laying hens;

2 mg/kg for cats;

5 mg/kg for other species and categories’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

4 mg/kg for piglets;

3 mg/kg for chickens for fattening and laying hens;

2 mg/kg for cats;

5 mg/kg for other species and categories

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b07054

Pentan-2-one

Additive composition

Pentan-2-one

Characterisation of the active substance

Pentan-2-one

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 5 H 10 O

CAS No 107-87-9

FLAVIS No: 07.054

Method of analysis

( 1 )

For the determination of pentan-2-one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

for piglets: 4 mg/kg, for chickens for fattening and laying hens: 3 mg/kg, for cats: 2 mg/kg and for other species and categories: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

4 mg/kg for piglets;

3 mg/kg for chickens for fattening and laying hens;

2 mg/kg for cats;

5 mg/kg for other species and categories’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

4 mg/kg for piglets;

3 mg/kg for chickens for fattening and laying hens;

2 mg/kg for cats;

5 mg/kg for other species and categories

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b07099

6-Methyl- hepta- 3,5-dien- 2-one

Additive composition

6-Methyl- hepta- 3,5-dien- 2-one

Characterisation of the active substance

6-Methyl- hepta- 3,5-dien- 2-one

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C 8 H 12 O

CAS No 1604-28-0

FLAVIS No: 07.099

Method of analysis

( 1 )

For the determination of 6-methyl- hepta- 3,5-dien- 2-one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

for pigs and poultry: 0,3 mg/kg, and for other species and categories: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

0,3 mg/kg for pigs and poultry;

0,5 mg/kg for other species and categories’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

0,3 mg/kg for pigs and poultry;

0,5 mg/kg for other species and categories

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b07113

Nonan- 3- one

Additive composition

Nonan- 3- one

Characterisation of the active substance

Nonan- 3- one

Produced by chemical synthesis

Purity: min. 95,9 %

Chemical formula: C 9 H 18 O

CAS No 925-78-0

FLAVIS No: 07.113

Method of analysis

( 1 )

For the determination of nonan- 3- one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

pigs and poultry: 0,3 mg/kg, for fish: 0,05 mg/kg and for other species and categories: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

0,3 mg/kg for pigs and poultry;

0,05 mg/kg for fish;

0,5 mg/kg for other species and categories’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

0,3 mg/kg for pigs and poultry;

0,05 mg/kg for fish;

0,5 mg/kg for other species and categories

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b07150

Decan- 2 -one

Additive composition

Decan- 2 -one

Characterisation of the active substance

Decan- 2 -one

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 10 H 20 O

CAS No 693-54-9

FLAVIS No: 07.150

Method of analysis

( 1 )

For the determination of decan- 2 -one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be:

for pigs and poultry: 0,3 mg/kg, and for other species and categories: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

0,3 mg/kg for pigs and poultry;

0,5 mg/kg for other species and categories’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

0,3 mg/kg for pigs and poultry;

0,5 mg/kg for other species and categories

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

2b09105

Isopropyl tetradecanoate

Additive composition

Isopropyl tetradecanoate

Characterisation of the active substance

Isopropyl tetradecanoate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C 17 H 34 O 2

CAS No 110-27-0

FLAVIS No 09.105

Method of analysis

( 1 )

For the determination of isopropyl tetradecanoate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

3.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

6 February 2027

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

4 articles

Cite this act

Commission Implementing Regulation (EU) 2017/55 of 14 December 2016 concerning the authorisation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32017R0055

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

EU-EurLex-Reuse-2011-833

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