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Regulation

Commission Implementing Regulation (EU) 2017/59 of 14 December 2016 concerning the authorisation of 1,1-dimethoxy-2-phenylethane, phenethyl formate, phenethyl octanoate, phenethyl isobutyrate, phenethyl 2-methyl-butyrate and phenethyl benzoate as feed additives for all animal species (Text with EEA relevance. )

CELEX
Implementing Regulation (EU) 2017/59
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

2b06006

1,1-Dimethoxy-2-phenylethane

Additive composition

1,1-Dimethoxy-2-phenylethane

Characterisation of the active substance

1,1-Dimethoxy-2-phenylethane

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 10 H 14 O 2

CAS number 101-48-4

FLAVIS No 06.006

Method of analysis

( 1 )

For the identification of 1,1-dimethoxy-2-phenylethane 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 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 contents of the active substance in complete feedingstuff with a moisture content of 12 % are 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

2b09083

Phenethyl formate

Additive composition

Phenethyl formate

Characterisation of the active substance

Phenethyl formate

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C 9 H 10 O 2

CAS number 104-62-1

FLAVIS No 09.083

Method of analysis

( 1 )

For the identification of phenethyl formate 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 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 contents of the active substance in complete feedingstuff with a moisture content of 12 % are 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

2b09262

Phenethyl octanoate

Additive composition

Phenethyl octanoate

Characterisation of the active substance

Phenethyl octanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 16 H 24 O 2

CAS number 5457-70-5

FLAVIS No 09.262

Method of analysis

( 1 )

For the identification of phenethyl 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 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 contents of the active substance in complete feedingstuff with a moisture content of 12 % are 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

2b09427

Phenethyl isobutyrate

Additive composition

Phenethyl isobutyrate

Characterisation of the active substance

Phenethyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 12 H 16 O 2

CAS number 103-48-0

FLAVIS No 09.427

Method of analysis

( 1 )

For the identification of phenethyl isobutyrate 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 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 contents of the active substance in complete feedingstuff with a moisture content of 12 % are 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

2b09538

Phenethyl 2-methyl-butyrate

Additive composition

Phenethyl 2-methyl-butyrate

Characterisation of the active substance

Phenethyl 2-methyl-butyrate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C 13 H 18 O 2

CAS number 24817-51-4

FLAVIS No 09.538

Method of analysis

( 1 )

For the identification of phenethyl 2-methyl-butyrate 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 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 contents of the active substance in complete feedingstuff with a moisture content of 12 % are 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

2b09774

Phenethyl benzoate

Additive composition

Phenethyl benzoate

Characterisation of the active substance

Phenethyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C 15 H 14 O 2

CAS number 94-47-3

FLAVIS No 09.774

Method of analysis

( 1 )

For the identification of phenethyl benzoate 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 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

( 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) 2017/59 of 14 December 2016 concerning the authorisation of 1,1-dimethoxy-2-phenylethane, phenethyl formate, phenethyl octanoate, phenethyl isobutyrate, phenethyl 2-methyl-butyrate and phenethyl benzoate as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32017R0059

© 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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