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Regulation

Commission Implementing Regulation (EU) 2018/248 of 15 February 2018 concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives for all animal species (Text with EEA relevance. )

CELEX
Implementing Regulation (EU) 2018/248
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 15 September 2018 in accordance with the rules applicable before 15 March 2018 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 as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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 as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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

2b14005

2,3-Diethylpyrazine

Additive composition

2,3-Diethylpyrazine

Characterisation of the active substance

2,3-Diethylpyrazine

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C 8 H 12 N 2

CAS number: 15707-24-1

FLAVIS No: 14.005

Method of analysis

( 1 )

For the determination of 2,3-diethylpyrazine 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.

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 %:

0,1 mg/kg for pigs and poultry.

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14025

2,5 or 6-Methoxy-3-methylpyrazine

Additive composition

2,5 or 6-Methoxy-3-methylpyrazine

Characterisation of the active substance

2,5 or 6-Methoxy-3-methylpyrazine

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C 6 H 8 ON 2

CAS number: 63450-30-6

FLAVIS No: 14.025

Method of analysis

( 1 )

For the determination of 2,5 or 6-methoxy-3-methylpyrazine 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.

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 %:

0,1 mg/kg for pigs and poultry.

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14049

2-Acetyl-3-ethylpyrazine

Additive composition

2-Acetyl-3-ethylpyrazine

Characterisation of the active substance

2-Acetyl-3-ethylpyrazine

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C 8 H 10 ON 2

CAS number: 32974-92-8

FLAVIS No: 14.049

Method of analysis

( 1 )

For the determination of 2-acetyl-3-ethylpyrazine 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.

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 %:

0,1 mg/kg for pigs and poultry.

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14056

2,3-Diethyl-5-methylpyrazine

Additive composition

2,3-Diethyl-5-methylpyrazine

Characterisation of the active substance

2,3-Diethyl-5-methylpyrazine

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C 9 H 14 N 2

CAS number: 18138-04-0

FLAVIS No: 14.056

Method of analysis

( 1 )

For the determination of 2,3-diethyl-5-methylpyrazine alcohol 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.

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 %:

0,1 mg/kg for pigs and poultry.

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14062

2-(sec-Butyl)-3-methoxypyrazine

Additive composition

2-(sec-Butyl)-3-methoxypyrazine

Characterisation of the active substance

2-(sec-Butyl)-3-methoxypyrazine

Produced by chemical synthesis

Purity: min. 99 % assay

Chemical formula: C 9 H 14 ON 2

CAS number: 24168-70-5

FLAVIS No: 14.062

Method of analysis

( 1 )

For the determination of 2-(sec-butyl)-3-methoxypyrazine 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.

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 %:

0,1 mg/kg for pigs and poultry.

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14112

2-Ethyl-3-methoxypyrazine

Additive composition

2-Ethyl-3-methoxypyrazine

Characterisation of the active substance

2-Ethyl-3-methoxypyrazine

Produced by chemical synthesis

Purity: min. 99 % assay

Chemical formula: C 7 H 10 N 2 O

CAS number: 25680-58-4

FLAVIS No: 14.112

Method of analysis

( 1 )

For the determination of 2-ethyl-3-methoxypyrazine 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.

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 %:

0,1 mg/kg for pigs and poultry

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14015

5,6,7,8-Tetrahydroquinoxaline

Additive composition

5,6,7,8-Tetrahydroquinoxaline

Characterisation of the active substance

5,6,7,8-Tetrahydroquinoxaline

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C 8 H 10 N 2

CAS number: 34413-35-9

FLAVIS No: 14.015

Method of analysis

( 1 )

For the determination of 5,6,7,8-tetrahydroquinoxaline 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.

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 %:

0,1 mg/kg for pigs and poultry.

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14022

2-Ethylpyrazine

Additive composition

2-Ethylpyrazine

Characterisation of the active substance

2-Ethylpyrazine

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C 6 H 8 N 2

CAS number: 13925-00-3

FLAVIS No: 14.022

Method of analysis

( 1 )

For the determination of 2-ethylpyrazine 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.

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 %:

0,1 mg/kg for pigs and poultry.

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

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,1 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.

15.3.2028

2b14028

5-Methylquinoxaline

Additive composition

5-Methylquinoxaline

Characterisation of the active substance

5-Methylquinoxaline

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C 9 H 8 N 2

CAS number: 13708-12-8

FLAVIS No: 14.028

Method of analysis

( 1 )

For the determination of 5-methylquinoxaline 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.

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 %:

0,05 mg/kg for pigs and poultry

0,08 mg/kg for other species and categories.’

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

5.

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

0,05 mg/kg for pigs and poultry.

0,08 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.

15.3.2028

( 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) 2018/248 of 15 February 2018 concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32018R0248

© 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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