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Regulation

Commission Implementing Regulation (EU) 2020/1396 of 5 October 2020 concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals (Text with EEA relevance)

CELEX
Implementing Regulation (EU) 2020/1396
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 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 26 October 2022 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b02012

-

Geraniol

Additive composition

Geraniol

Characterisation of the active substance

Geraniol

Produced by fractional distillation of an essential oil or by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 10 H 18 O

CAS number: 106-24-1

FLAVIS No: 02.012

Method of analysis

( 1 )

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

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

The recommended maximum content of the active substance shall be 25 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 25 mg/kg.

6.

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

26.10.2030

2b02029

-

3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

Additive composition

3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

Characterisation of the active substance

3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C 15 H 26 O

CAS number: 4602-84-0

FLAVIS No: 02.029

Method of analysis

( 1 )

For the determination of 3,7,11-Trimethyldodeca-2,6,10-trien-1-ol in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b02058

-

(Z)-Nerol

Additive composition

(Z)-Nerol

Characterisation of the active substance

(Z)-Nerol

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 10 H 18 O

CAS number: 106-25-2

FLAVIS No: 02.058

Method of analysis

( 1 )

For the determination of (Z)-nerol in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b05020

-

Citral

Additive composition

Citral

Characterisation of the active substance

Citral

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C 10 H 16 O

CAS number: 5392-40-5

FLAVIS No: 05.020

Method of analysis

( 1 )

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

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

The recommended maximum content of the active substance shall be 25 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 25 mg/kg.

6.

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

26.10.2030

2b09011

-

Geranyl acetate

Additive composition

Geranyl acetate

Characterisation of the active substance

Geranyl acetate

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C 12 H 20 O 2

CAS number: 105-87-3

FLAVIS No: 09.011

Method of analysis

( 1 )

For the determination of geranyl acetate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b09048

-

Geranyl butyrate

Additive composition

Geranyl butyrate

Characterisation of the active substance

Geranyl butyrate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C 14 H 24 O 2

CAS number: 106-29-6

FLAVIS No: 09.048

Method of analysis

( 1 )

For the determination of geranyl butyrate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b09076

-

Geranyl formate

Additive composition

Geranyl formate

Characterisation of the active substance

Geranyl formate

Produced by chemical synthesis

Purity: min. 94 % assay

Chemical formula: C 11 H 18 O 2

CAS number: 105-86-2

FLAVIS No: 09.076

Method of analysis

( 1 )

For the determination of geranyl formate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b09128

-

Geranyl propionate

Additive composition

Geranyl propionate

Characterisation of the active substance

Geranyl propionate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C 13 H 22 O 2

CAS number: 105-90-8

FLAVIS No: 09.128

Method of analysis

( 1 )

For the determination of geranyl propionate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b09169

-

Neryl propionate

Additive composition

Neryl propionate

Characterisation of the active substance

Neryl propionate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 13 H 22 O 2

CAS number: 105-91-9

FLAVIS No: 09.169

Method of analysis

( 1 )

For the determination of neryl propionate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 %exceeds 5 mg/kg.

6.

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

26.10.2030

2b09212

-

Neryl formate

Additive composition

Neryl formate

Characterisation of the active substance

Neryl formate

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C 11 H 18 O 2

CAS number: 2142-94-1

FLAVIS No: 09.212

Method of analysis

( 1 )

For the determination of neryl formate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b09213

-

Neryl acetate

Additive composition

Neryl acetate

Characterisation of the active substance

Neryl acetate

Produced by chemical synthesis

Purity: min. 93 % assay

Chemical formula: C 12 H 20 O 2

CAS number: 141-12-8

FLAVIS No: 09.213

Method of analysis

( 1 )

For the determination of neryl acetate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

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

6.

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

26.10.2030

2b09424

-

Neryl isobutyrate

Additive composition

Neryl isobutyrate

Characterisation of the active substance

Neryl isobutyrate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C 14 H 24 O 2

CAS number: 2345-24-6

FLAVIS No: 09.424

Method of analysis

( 1 )

For the determination of neryl isobutyrate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b09431

-

Geranyl isobutyrate

Additive composition

Geranyl isobutyrate

Characterisation of the active substance

Geranyl isobutyrate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 14 H 24 O 2

CAS number: 2345-26-8

FLAVIS No: 09.431

Method of analysis

( 1 )

For the determination of geranyl isobutyrate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

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

4.

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

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

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

6.

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

26.10.2030

2b09692

-

Prenyl acetate

Additive composition

Prenyl acetate

Characterisation of the active substance

Prenyl acetate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 7 H 12 O 2

CAS number: 1191-16-8

FLAVIS No: 09.692

Method of analysis

( 1 )

For the determination of prenyl acetate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

-

-

-

1.

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

2.

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

3.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 1 mg/kg.

6.

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

26.10.2030

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

4 articles

Cite this act

Commission Implementing Regulation (EU) 2020/1396 of 5 October 2020 concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32020R1396

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

EU-EurLex-Reuse-2011-833

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