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Regulation

Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species (Text with EEA relevance. )

CELEX
Implementing Regulation (EU) 2018/250
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

2b13002

Methyl 2-furoate

Additive composition

Methyl 2-furoate

Characterisation of the active substance

Methyl 2-furoate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C 6 H 6 O 3

CAS number: 611-13-2

FLAVIS No: 13.002

Method of analysis

( 1 )

For the determination of methyl 2-furoate 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 %: 0,5 mg/kg.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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: 0,5 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.

15.3.2028

2b13016

Bis-(2-methyl-3-furyl) disulfide

Additive composition

Bis-(2-methyl-3-furyl) disulfide

Characterisation of the active substance

Bis-(2-methyl-3-furyl) disulfide

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C 10 H 10 O 2 S 2

CAS number: 28588-75-2

FLAVIS No: 13.016

Method of analysis

( 1 )

For the determination of bis-(2-methyl-3-furyl) disulfide 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13018

Furfural

Additive composition

Furfural

Characterisation of the active substance

Furfural

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 5 H 4 O 2

CAS number: 98-01-1

FLAVIS No: 13.018

Method of analysis

( 1 )

For the determination of furfural 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 %: 5 mg/kg.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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: 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.

15.3.2028

2b13019

Furfuryl alcohol

Additive composition

Furfuryl alcohol

Characterisation of the active substance

Furfuryl alcohol

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C 5 H 6 O 2

CAS number: 98-00-0

FLAVIS No: 13.019

Method of analysis

( 1 )

For the determination of furfuryl 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 %: 5 mg/kg.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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: 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.

15.3.2028

2b13026

2-Furanmethanethiol

Additive composition

2-Furanmethanethiol

Characterisation of the active substance

2-Furanmethanethiol

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C 5 H 6 OS

CAS number: 98-02-2

FLAVIS No: 13.026

Method of analysis

( 1 )

For the determination of 2-furanmethanethiol 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13033

S-Furfuryl acetothioate

Additive composition

S-furfuryl acetothioate

Characterisation of the active substance

S-furfuryl acetothioate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 7 H 8 O 2 S

CAS number: 13678-68-7

FLAVIS No: 13.033

Method of analysis

( 1 )

For the determination of S-furfuryl acetothioate 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13050

Difurfuryl disulfide

Additive composition

Difurfuryl disulfide

Characterisation of the active substance

Difurfuryl disulfide

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C 10 H 10 O 2 S 2

CAS number: 4437-20-1

FLAVIS No: 13.050

Method of analysis

( 1 )

For the determination of difurfuryl disulfide 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13053

Methyl furfuryl sulfide

Additive composition

Methyl furfuryl sulfide

Characterisation of the active substance

Methyl furfuryl sulfide

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C 6 H 8 OS

CAS number: 1438-91-1

FLAVIS No: 13.053

Method of analysis

( 1 )

For the determination of methyl furfuryl sulfide 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13055

2-Methylfuran-3-thiol

Additive composition

2-Methylfuran-3-thiol

Characterisation of the active substance

2-Methylfuran-3-thiol

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 5 H 6 OS

CAS number: 28588-74-1

FLAVIS No: 13.055

Method of analysis

( 1 )

For the determination of 2-methylfuran-3-thiol 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13064

Methyl furfuryl disulfide

Additive composition

Methyl furfuryl disulfide

Characterisation of the active substance

Methyl furfuryl disulfide

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C 6 H 8 OS 2

CAS number: 57500-00-2

FLAVIS No: 13.064

Method of analysis

( 1 )

For the determination of methyl furfuryl disulfide 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13079

Methyl 2-methyl-3-furyl disulfide

Additive composition

Methyl 2-methyl-3-furyl disulfide

Characterisation of the active substance

Methyl 2-methyl-3-furyl disulfide

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C 6 H 8 OS 2

CAS number: 65505-17-1

FLAVIS No: 13.079

Method of analysis

( 1 )

For the determination of methyl 2-methyl-3-furyl disulfide 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.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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.

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

2b13128

Furfuryl acetate

Additive composition

Furfuryl acetate

Characterisation of the active substance

Furfuryl acetate

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C 7 H 8 O 3

CAS number: 623-17-6

FLAVIS No: 13.128

Method of analysis

( 1 )

For the determination of furfuryl acetate 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 %: 0,5 mg/kg.’

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 premixtures where the use level suggested on the label of the premixture would result in exceeding the level 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: 0,5 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.

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) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species (Text with EEA relevance. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32018R0250

© 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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