Commission Implementing Regulation (EU) 2018/248Show full title

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)

ANNEX

a

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

Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd 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
2b140052,3-Diethylpyrazine

Additive composition

2,3-Diethylpyrazine

Characterisation of the active substance

2,3-Diethylpyrazine

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C8H12N2

CAS number: 15707-24-1

FLAVIS No: 14.005

Method of analysis a

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
2b140252,5 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: C6H8ON2

CAS number: 63450-30-6

FLAVIS No: 14.025

Method of analysis a

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
2b140492-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: C8H10ON2

CAS number: 32974-92-8

FLAVIS No: 14.049

Method of analysis a

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
2b140562,3-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: C9H14N2

CAS number: 18138-04-0

FLAVIS No: 14.056

Method of analysis a

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
2b140622-(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: C9H14ON2

CAS number: 24168-70-5

FLAVIS No: 14.062

Method of analysis a

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
2b141122-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: C7H10N2O

CAS number: 25680-58-4

FLAVIS No: 14.112

Method of analysis a

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
2b140155,6,7,8-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: C8H10N2

CAS number: 34413-35-9

FLAVIS No: 14.015

Method of analysis a

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
2b140222-Ethylpyrazine

Additive composition

2-Ethylpyrazine

Characterisation of the active substance

2-Ethylpyrazine

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C6H8N2

CAS number: 13925-00-3

FLAVIS No: 14.022

Method of analysis a

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
2b140285-Methylquinoxaline

Additive composition

5-Methylquinoxaline

Characterisation of the active substance

5-Methylquinoxaline

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H8N2

CAS number: 13708-12-8

FLAVIS No: 14.028

Method of analysis a

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