ISSN 1977-0677

Official Journal

of the European Union

L 13
European flag  

English edition

Legislation

Volume 60
17 January 2017

Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Implementing Regulation (EU) 2017/53 of 14 December 2016 concerning the authorisation of butan-1-ol, hexan-1-ol, octan-1-ol, nonan-1-ol, dodecan-1-ol, heptan-1-ol, decan-1-ol, pentan-1-ol, ethanol, acetaldehyde, propanal, butanal, pentanal, hexanal, octanal, decanal, dodecanal, nonanal, heptanal, undecanal, 1,1-diethoxyethane, formic acid, acetic acid, propionic acid, valeric acid, hexanoic acid, octanoic acid, decanoic acid, dodecanoic acid, oleic acid, hexadecanoic acid, tetradecanoic acid, heptanoic acid, nonanoic acid, ethyl acetate, propyl acetate, butyl acetate, hexyl acetate, octyl acetate, nonyl acetate, decyl acetate, dodecyl acetate, heptyl acetate, methyl acetate, methyl butyrate, butyl butyrate, pentyl butyrate, hexyl butyrate, octyl butyrate, ethyl decanoate, ethyl hexanoate, propyl hexanoate, pentyl hexanoate, hexyl hexanoate, methyl hexanoate, ethyl formate, ethyl dodecanoate, ethyl tetradecanoate, ethyl nonanoate, ethyl octanoate, ethyl propionate, methyl propionate, ethyl valerate, butyl valerate, ethyl hex-3-enoate, ethyl hexadecanoate, ethyl trans-2-butenoate, ethyl undecanoate, butyl isovalerate, hexyl isobutyrate, methyl 2-methylbutyrate, hexyl 2-methylbutyrate, triethyl citrate, hexyl isovalerate and methyl 2-methylvalerate as feed additives for all animal species ( 1 )

1

 

*

Commission Implementing Regulation (EU) 2017/54 of 14 December 2016 concerning the authorisation of 2-methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate as feed additives for all animal species ( 1 )

80

 

*

Commission Implementing Regulation (EU) 2017/55 of 14 December 2016 concerning the authorisation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate as feed additives for all animal species ( 1 )

112

 

*

Commission Implementing Regulation (EU) 2017/56 of 14 December 2016 concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone as feed additives for all animal species ( 1 )

129

 

*

Commission Implementing Regulation (EU) 2017/57 of 14 December 2016 concerning the authorisation of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran as feed additives for all animal species ( 1 )

153

 

*

Commission Implementing Regulation (EU) 2017/58 of 14 December 2016 concerning the authorisation of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate as feed additives for all animal species ( 1 )

159

 

*

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 ( 1 )

167

 

*

Commission Implementing Regulation (EU) 2017/60 of 14 December 2016 concerning the authorisation of isoeugenol as a feed additive for pigs, ruminants and horses except those producing milk for human consumption and pets ( 1 )

177

 

*

Commission Implementing Regulation (EU) 2017/61 of 14 December 2016 concerning the authorisation of 4-allyl-2,6-dimethoxyphenol and eugenyl acetate as feed additives for all animal species except for fish and poultry ( 1 )

181

 

*

Commission Implementing Regulation (EU) 2017/62 of 14 December 2016 concerning the authorisation of 3-(methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane as feed additives for all animal species ( 1 )

186

 

*

Commission Implementing Regulation (EU) 2017/63 of 14 December 2016 concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species ( 1 )

214

 

*

Commission Implementing Regulation (EU) 2017/64 of 14 December 2016 concerning the authorisation of glycyrrhizic acid ammoniated as a feed additive for all animal species ( 1 )

242

 

*

Commission Implementing Regulation (EU) 2017/65 of 14 December 2016 concerning the authorisation of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene as feed additives for all animal species ( 1 )

246

 

*

Commission Implementing Regulation (EU) 2017/66 of 14 December 2016 concerning the authorisation of tannic acid as a feed additive for all animal species ( 1 )

259

 

 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

II Non-legislative acts

REGULATIONS

17.1.2017   

EN

Official Journal of the European Union

L 13/1

COMMISSION IMPLEMENTING REGULATION (EU) 2017/53

of 14 December 2016

concerning the authorisation of butan-1-ol, hexan-1-ol, octan-1-ol, nonan-1-ol, dodecan-1-ol, heptan-1-ol, decan-1-ol, pentan-1-ol, ethanol, acetaldehyde, propanal, butanal, pentanal, hexanal, octanal, decanal, dodecanal, nonanal, heptanal, undecanal, 1,1-diethoxyethane, formic acid, acetic acid, propionic acid, valeric acid, hexanoic acid, octanoic acid, decanoic acid, dodecanoic acid, oleic acid, hexadecanoic acid, tetradecanoic acid, heptanoic acid, nonanoic acid, ethyl acetate, propyl acetate, butyl acetate, hexyl acetate, octyl acetate, nonyl acetate, decyl acetate, dodecyl acetate, heptyl acetate, methyl acetate, methyl butyrate, butyl butyrate, pentyl butyrate, hexyl butyrate, octyl butyrate, ethyl decanoate, ethyl hexanoate, propyl hexanoate, pentyl hexanoate, hexyl hexanoate, methyl hexanoate, ethyl formate, ethyl dodecanoate, ethyl tetradecanoate, ethyl nonanoate, ethyl octanoate, ethyl propionate, methyl propionate, ethyl valerate, butyl valerate, ethyl hex-3-enoate, ethyl hexadecanoate, ethyl trans-2-butenoate, ethyl undecanoate, butyl isovalerate, hexyl isobutyrate, methyl 2-methylbutyrate, hexyl 2-methylbutyrate, triethyl citrate, hexyl isovalerate and methyl 2-methylvalerate as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Butan-1-ol, Hexan-1-ol, octan-1-ol, nonan-1-ol, dodecan-1-ol, heptan-1-ol, decan-1-ol, pentan-1-ol, ethanol, acetaldehyde, propanal, butanal, pentanal, hexanal, octanal, decanal, dodecanal, nonanal, heptanal, undecanal, 1,1-diethoxyethane, formic acid, acetic acid, propionic acid, valeric acid, hexanoic acid, octanoic acid, decanoic acid, dodecanoic acid, oleic acid, hexadecanoic acid, tetradecanoic acid, heptanoic acid, nonanoic acid, ethyl acetate, propyl acetate, butyl acetate, hexyl acetate, octyl acetate, nonyl acetate, decyl acetate, dodecyl acetate, heptyl acetate, methyl acetate, methyl butyrate, butyl butyrate, pentyl butyrate, hexyl butyrate, octyl butyrate, ethyl decanoate, ethyl hexanoate, propyl hexanoate, pentyl hexanoate, hexyl hexanoate, methyl hexanoate, ethyl formate, ethyl dodecanoate, ethyl tetradecanoate, ethyl nonanoate, ethyl octanoate, ethyl propionate, methyl propionate, ethyl valerate, butyl valerate, ethyl hex-3-enoate, ethyl hexadecanoate, ethyl trans-2-butenoate, ethyl undecanoate, butyl isovalerate, hexyl isobutyrate, methyl 2-methylbutyrate, hexyl 2-methylbutyrate, triethyl citrate, hexyl isovalerate and methyl 2-methylvalerate hereinafter referred to as ‘the substances concerned’ were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 March 2013 (3) that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that those substances are flavouring agents authorised in food for which the efficacy is demonstrated as the functions of the additive applied for feed use and described for food use are similar.

(5)

The Authority concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the Method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. Maximum recommended contents should be set up for those substances. Those substances may be used within a compound feed subsequently administered via water.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional Measures

1.   The substances 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 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 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2013;11(4):3169.

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

2b02004

—

Butan-1-ol

Additive composition

Butan-1-ol

Characterisation of the active substance

Butan-1-ol

Produced by chemical synthesis

Purity: min. 99,5 %

Chemical formula: C4H10O

CAS number 71-36-3

FLAVIS 02.004

Method of analysis  (1)

For the determination of Butan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02005

—

Hexan-1-ol

Additive composition

Hexan-1-ol

Characterisation of the active substance

Hexan-1-ol

Produced by chemical synthesis

Purity: min. 96,5 %

Chemical formula: C6H14O

CAS number 111-27-3

FLAVIS 02.005

Method of analysis  (1)

For the determination of Hexan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02006

—

Octan-1-ol

Additive composition

Octan-1-ol

Characterisation of the active substance

Octan-1-ol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H18O

CAS number 111-87-5

FLAVIS 02.006

Method of analysis  (1)

For the determination of Octan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b02007

—

Nonan-1-ol

Additive composition

Nonan-1-ol

Characterisation of the active substance

Nonan-1-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C9H20O

CAS number 143-08-8

FLAVIS 02.007

Method of analysis  (1)

For the determination of Nonan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b02008

—

Dodecan-1-ol

Additive composition

Dodecan-1-ol

Characterisation of the active substance

Dodecan-1-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C12H26O

CAS number 112-53-8

FLAVIS 02.008

Method of analysis  (1)

For the determination of Dodecan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02021

—

Heptan-1-ol

Additive composition

Heptan-1-ol

Characterisation of the active substance

Heptan-1-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C7H16O

CAS number 111-70-6

FLAVIS 02.021

Method of analysis  (1)

For the determination of Heptan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02024

—

Decan-1-ol

Additive composition

Decan-1-ol

Characterisation of the active substance

Decan-1-ol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H22O

CAS number 112-30-1

FLAVIS 02.024

Method of analysis  (1)

For the determination of Decan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02040

—

Pentan-1-ol

Additive composition

Pentan-1-ol

Characterisation of the active substance

Pentan-1-ol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C5H12O

CAS number 71-41-0

FLAVIS 02.040

Method of analysis  (1)

For the determination of Pentan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02078

—

Ethanol

Additive composition

Ethanol

Characterisation of the active substance

Ethanol

Produced by chemical synthesis or enzymatic fermentation.

Purity: min. 95 %

Chemical formula: C2H6O

CAS number 64-17-5

FLAVIS 02.078

Method of analysis  (1)

For the determination of Ethanol 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05001

—

Acetaldehyde

Additive composition

Acetaldehyde

Characterisation of the active substance

Acetaldehyde

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C2H4O

CAS number 75-07-0

FLAVIS 05.001

Method of analysis  (1)

For the determination of Acetaldehyde 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05002

—

Propanal

Additive composition

Propanal

Characterisation of the active substance

Propanal

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C3H6O

CAS number 123-38-6

FLAVIS 05.002

Method of analysis  (1)

For the determination of Propanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05003

—

Butanal

Additive composition

Butanal

Characterisation of the active substance

Butanal

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H8O

CAS number 123-72-8

FLAVIS 05.003

Method of analysis  (1)

For the determination of Butanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05005

—

Pentanal

Additive composition

Pentanal

Characterisation of the active substance

Pentanal

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C5H10O

CAS number 110-62-3

FLAVIS 05.005

Method of analysis  (1)

For the determination of Pentanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05008

—

Hexanal

Additive composition

Hexanal

Characterisation of the active substance

Hexanal

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C6H12O

CAS number 66-25-1

FLAVIS 05.008

Method of analysis  (1)

For the determination of Hexanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05009

—

Octanal

Additive composition

Octanal

Characterisation of the active substance

Octanal

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C8H16O

CAS number 124-13-0

FLAVIS 05.009

Method of analysis  (1)

For the determination of Octanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05010

—

Decanal

Additive composition

Decanal

Characterisation of the active substance

Decanal

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C10H20O

CAS number 112-31-2

FLAVIS 05.010

Method of analysis  (1)

For the determination of Decanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05011

—

Dodecanal

Additive composition

Dodecanal

Characterisation of the active substance

Dodecanal

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C12H24O

CAS number 112-54-9

FLAVIS 05.011

Method of analysis  (1)

For the determination of Dodecanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05025

—

Nonanal

Additive composition

Nonanal

Characterisation of the active substance

Nonanal

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C9H18O

CAS number 124-19-6

FLAVIS 05.025

Method of analysis  (1)

For the determination of Nonanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05031

—

Heptanal

Additive composition

Heptanal

Characterisation of the active substance

Heptanal

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C7H14O

CAS number 111-71-7

FLAVIS 05.031

Method of analysis  (1)

For the determination of Heptanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05034

—

Undecanal

Additive composition

Undecanal

Characterisation of the active substance

Undecanal

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C11H22O

CAS number 112-44-7

FLAVIS 05.034

Method of analysis  (1)

For the determination of Undecanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b06001

—

1,1-Diethoxyethane

Additive composition

1,1-Diethoxyethane

Characterisation of the active substance

1,1-Diethoxyethane

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C6H14O2

CAS number 105-57-7

FLAVIS 06.001

Method of analysis  (1)

For the determination of 1,1-Diethoxyethane 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08001

—

Formic acid

Additive composition

Formic acid

Characterisation of the active substance

Formic acid

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: CH2O2

CAS number 64-18-6

FLAVIS 08.001

Method of analysis  (1)

For the determination of Formic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08002

—

Acetic acid

Additive composition

Acetic acid

Characterisation of the active substance

Acetic acid

Produced by chemical synthesis

Purity: min. 99,5 %

Chemical formula: C2H4O2

CAS number 64-19-7

FLAVIS 08.002

Method of analysis  (1)

For the determination of Acetic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

1k280

—

Propionic acid

Additive composition

Propionic acid

Characterisation of the active substance

Propionic acid

Produced by chemical synthesis

Purity: min. 99,5 %

Non-volatile residue ≤ 0,01 % when dried at 140 °C to constant weight.

Aldehydes ≤ 0,1 % expressed as formaldehyde

Chemical formula: C3H6O2

CAS number 79-09-4

FLAVIS 08.003

Method of analysis  (1)

For the determination of Propionic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08007

—

Valeric acid

Additive composition

Valeric acid

Characterisation of the active substance

Valeric acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C5H10O2

CAS number 109-52-4

FLAVIS 08.007

Method of analysis  (1)

For the determination of Valeric acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08009

—

Hexanoic acid

Additive composition

Hexanoic acid

Characterisation of the active substance

Hexanoic acid

Produced by chemical modification of extracted fats

Purity: min. 98 %

Chemical formula: C6H12O2

CAS number 142-62-1

FLAVIS 08.009

Method of analysis  (1)

For the determination of Hexanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08010

—

Octanoic acid

Additive composition

Octanoic acid

Characterisation of the active substance

Octanoic acid

Produced by fermentation followed by fractional distillation.

Purity: min. 97 %

Chemical formula: C8H16O2

CAS number 124-07-2

FLAVIS 08.010

Method of analysis  (1)

For the determination of octanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08011

—

Decanoic acid

Additive composition

Decanoic acid

Characterisation of the active substance

Decanoic acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H20O2

CAS number 334-48-5

FLAVIS 08.011

Method of analysis  (1)

For the determination of Decanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08012

—

Dodecanoic acid

Additive composition

Dodecanoic acid

Characterisation of the active substance

Dodecanoic acid

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C12H24O2

CAS number 143-07-7

FLAVIS 08.012

Method of analysis  (1)

For the determination of Dodecanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08013

—

Oleic acid

Additive composition

Oleic acid

Characterisation of the active substance

Oleic acid

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C18H34O2

CAS number 112-80-1

FLAVIS 08.013

Method of analysis  (1)

For the determination of Oleic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08014

—

Hexadecanoic acid

Additive composition

Hexadecanoic acid

Characterisation of the active substance

Hexadecanoic acid

Produced by chemical synthesis

Purity: min. 80 %

Chemical formula: C16H32O2

CAS number 57-10-3

FLAVIS 08.014

Method of analysis  (1)

For the determination of Hexadecanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08016

—

Tetradecanoic acid

Additive composition

Tetradecanoic acid

Characterisation of the active substance

Tetradecanoic acid

Produced by chemical synthesis

Purity: min. 94 %

Chemical formula: C14H28O2

CAS number 544-63-8

FLAVIS 08.016

Method of analysis  (1)

For the determination of Tetradecanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08028

—

Heptanoic acid

Additive composition

Heptanoic acid

Characterisation of the active substance

Heptanoic acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H14O2

CAS number 111-14-8

FLAVIS 08.028

Method of analysis  (1)

For the determination of Heptanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08029

—

Nonanoic acid

Additive composition

Nonanoic acid

Characterisation of the active substance

Nonanoic acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H18O2

CAS number 112-05-0

FLAVIS 08.029

Method of analysis  (1)

For the determination of Nonanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09001

—

Ethyl acetate

Additive composition

Ethyl acetate

Characterisation of the active substance

Ethyl acetate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C4H8O2

CAS number 141-78-6

FLAVIS 09.001

Method of analysis  (1)

For the determination of Ethyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09002

—

Propyl acetate

Additive composition

Propyl acetate

Characterisation of the active substance

Propyl acetate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C5H10O2

CAS number 109-60-4

FLAVIS 09.002

Method of analysis  (1)

For the determination of Propyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09004

—

Butyl acetate

Additive composition

Butyl acetate

Characterisation of the active substance

Butyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H12O2

CAS number 123-86-4

FLAVIS 09.004

Method of analysis  (1)

For the determination of Butyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09006

—

Hexyl acetate

Additive composition

Hexyl acetate

Characterisation of the active substance

Hexyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H12O2

CAS number 142-92-7

FLAVIS 09.006

Method of analysis  (1)

For the determination of Hexyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09007

—

Octyl acetate

Additive composition

Octyl acetate

Characterisation of the active substance

Octyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H20O2

CAS number 112-14-1

FLAVIS 09.007

Method of analysis  (1)

For the determination of Octyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09008

—

Nonyl acetate

Additive composition

Nonyl acetate

Characterisation of the active substance

Nonyl acetate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C11H22O2

CAS number 143-13-5

FLAVIS 09.008

Method of analysis  (1)

For the determination of Nonyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09009

—

Decyl acetate

Additive composition

Decyl acetate

Characterisation of the active substance

Decyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H24O2

CAS number 112-17-4

FLAVIS 09.009

Method of analysis  (1)

For the determination of Decyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09010

—

Dodecyl acetate

Additive composition

Dodecyl acetate

Characterisation of the active substance

Dodecyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C14H28O2

CAS number 112-66-3

FLAVIS 09.010

Method of analysis  (1)

For the determination of Dodecyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09022

—

Heptyl acetate

Additive composition

Heptyl acetate

Characterisation of the active substance

Heptyl acetate

Produced by chemical synthesis

Purity: min. 97,5 %

Chemical formula: C9H18O2

CAS number 112-06-1

FLAVIS 09.022

Method of analysis  (1)

For the determination of Heptyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09023

—

Methyl acetate

Additive composition

Methyl acetate

Characterisation of the active substance

Methyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C3H6O2

CAS number 79-20-9

FLAVIS 09.023

Method of analysis  (1)

For the determination of Methyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09038

—

Methyl butyrate

Additive composition

Methyl butyrate

Characterisation of the active substance

Methyl butyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C5H10O2

CAS number 623-42-7

FLAVIS 09.038

Method of analysis  (1)

For the determination of Methyl butyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09042

—

Butyl butyrate

Additive composition

Butyl butyrate

Characterisation of the active substance

Butyl butyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H16O2

CAS number 109-21-7

FLAVIS 09.042

Method of analysis  (1)

For the determination of Butyl butyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09044

—

Pentyl butyrate

Additive composition

Pentyl butyrate

Characterisation of the active substance

Pentyl butyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H18O2

CAS number 540-18-1

FLAVIS 09.044

Method of analysis  (1)

For the determination of Pentyl butyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09045

—

Hexyl butyrate

Additive composition

Hexyl butyrate

Characterisation of the active substance

Hexyl butyrate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C10H20O2

CAS number 2639-63-6

FLAVIS 09.045

Method of analysis  (1)

For the determination of Hexyl butyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09046

—

Octyl butyrate

Additive composition

Octyl butyrate

Characterisation of the active substance

Octyl butyrate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C12H24O2

CAS number 110-39-4

FLAVIS 09.046

Method of analysis  (1)

For the determination of Octyl butyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09059

—

Ethyl decanoate

Additive composition

Ethyl decanoate

Characterisation of the active substance

Ethyl decanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H24O2

CAS number 110-38-3

FLAVIS 09.059

Method of analysis  (1)

For the determination of Ethyl decanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09060

—

Ethyl hexanoate

Additive composition

Ethyl hexanoate

Characterisation of the active substance

Ethyl hexanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H16O2

CAS number 123-66-0

FLAVIS 09.060

Method of analysis  (1)

For the determination of Ethyl hexanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09061

—

Propyl hexanoate

Additive composition

Propyl hexanoate

Characterisation of the active substance

Propyl hexanoate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C9H18O2

CAS number 626-77-7

FLAVIS 09.061

Method of analysis  (1)

For the determination of Propyl hexanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09065

—

Pentyl hexanoate

Additive composition

Pentyl hexanoate

Characterisation of the active substance

Pentyl hexanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H22O2

CAS number 540-07-8

FLAVIS 09.065

Method of analysis  (1)

For the determination of Pentyl hexanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09066

—

Hexyl hexanoate

Additive composition

Hexyl hexanoate

Characterisation of the active substance

Hexyl hexanoate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C12H24O2

CAS number 6378-65-0

FLAVIS 09.066

Method of analysis  (1)

For the determination of Hexyl hexanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09069

—

Methyl hexanoate

Additive composition

Methyl hexanoate

Characterisation of the active substance

Methyl hexanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H14O2

CAS number 106-70-7

FLAVIS 09.069

Method of analysis  (1)

For the determination of Methyl hexanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09072

—

Ethyl formate

Additive composition

Ethyl formate

Characterisation of the active substance

Ethyl formate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C3H6O2

CAS number 109-94-4

FLAVIS 09.072

Method of analysis  (1)

For the determination of Ethyl formate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09099

—

Ethyl dodecanoate

Additive composition

Ethyl dodecanoate

Characterisation of the active substance

Ethyl dodecanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C14H28O2

CAS number 106-33-2

FLAVIS 09.099

Method of analysis  (1)

For the determination of Ethyl dodecanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09104

—

Ethyl tetradecanoate

Additive composition

Ethyl tetradecanoate

Characterisation of the active substance

Ethyl tetradecanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C16H32O2

CAS number 124-06-1

FLAVIS 09.104

Method of analysis  (1)

For the determination of Ethyl tetradecanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09107

—

Ethyl nonanoate

Additive composition

Ethyl nonanoate

Characterisation of the active substance

Ethyl nonanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H22O2

CAS number 123-29-5

FLAVIS 09.107

Method of analysis  (1)

For the determination of Ethyl nonanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09111

—

Ethyl octanoate

Additive composition

Ethyl octanoate

Characterisation of the active substance

Ethyl octanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H20O2

CAS number 106-32-1

FLAVIS 09.111

Method of analysis  (1)

For the determination of Ethyl octanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09121

—

Ethyl propionate

Additive composition

Ethyl propionate

Characterisation of the active substance

Ethyl propionate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C5H10O2

CAS number 105-37-3

FLAVIS 09.121

Method of analysis  (1)

For the determination of Ethyl propionate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09134

—

Methyl propionate

Additive composition

Methyl propionate

Characterisation of the active substance

Methyl propionate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C4H8O2

CAS number 554-12-1

FLAVIS 09.134

Method of analysis  (1)

For the determination of Methyl propionate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09147

—

Ethyl valerate

Additive composition

Ethyl valerate

Characterisation of the active substance

Ethyl valerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H14O2

CAS number 539-82-2

FLAVIS 09.147

Method of analysis  (1)

For the determination of Ethyl valerate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09148

—

Butyl valerate

Additive composition

Butyl valerate

Characterisation of the active substance

Butyl valerate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C9H18O2

CAS number 591-68-4

FLAVIS 09.148

Method of analysis  (1)

For the determination of Butyl valerate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09191

—

Ethyl hex-3-enoate

Additive composition

Ethyl hex-3-enoate

Characterisation of the active substance

Ethyl hex-3-enoate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C8H14O2

CAS number 2396-83-0

FLAVIS 09.191

Method of analysis  (1)

For the identification of Ethyl hex-3-enoate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09193

—

Ethyl hexadecanoate

Additive composition

Ethyl hexadecanoate

Characterisation of the active substance

Ethyl hexadecanoate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C18H36O2

CAS number 628-97-7

FLAVIS 09.193

Method of analysis  (1)

For the determination of Ethyl hexadecanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09248

—

Ethyl trans-2-butenoate

Additive composition

Ethyl trans-2-butenoate

Characterisation of the active substance

Ethyl trans-2-butenoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H10O2

CAS number 623-70-1

FLAVIS 09.248

Method of analysis  (1)

For the identification of Ethyl trans-2-butenoate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09274

—

Ethyl undecanoate

Additive composition

Ethyl undecanoate

Characterisation of the active substance

Ethyl undecanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C13H26O2

CAS number 627-90-7

FLAVIS 09.274

Method of analysis  (1)

For the determination of Ethyl undecanoate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09449

—

Butyl isovalerate

Additive composition

Butyl isovalerate

Characterisation of the active substance

Butyl isovalerate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C9H18O2

CAS number 109-19-3

FLAVIS 09.449

Method of analysis  (1)

For the identification of Butyl isovalerate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09478

—

Hexyl isobutyrate

Additive composition

Hexyl isobutyrate

Characterisation of the active substance

Hexyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H20O2

CAS number 2349-07-7

FLAVIS 09.478

Method of analysis  (1)

For the identification of Hexyl 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09483

—

Methyl 2-methylbutyrate

Additive composition

Methyl 2-methylbutyrate

Characterisation of the active substance

Methyl 2-methylbutyrate

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C6H12O2

CAS number 868-57-5

FLAVIS 09.483

Method of analysis  (1)

For the identification of Methyl 2-methylbutyrate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09507

—

Hexyl 2-methylbutyrate

Additive composition

Hexyl 2-methylbutyrate

Characterisation of the active substance

Hexyl 2-methylbutyrate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C11H22O2

CAS number 10032-15-2

FLAVIS 09.507

Method of analysis  (1)

For the identification of Hexyl 2-methylbutyrate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09512

—

Triethyl citrate

Additive composition

Triethyl citrate

Characterisation of the active substance

Triethyl citrate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C12H20O7

CAS number 77-93-0

FLAVIS 09.512

Method of analysis  (1)

For the determination of Triethyl citrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09529

—

Hexyl isovalerate

Additive composition

Hexyl isovalerate

Characterisation of the active substance

Hexyl isovalerate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C11H22O2

CAS number 10032-13-0

FLAVIS 09.529

Method of analysis  (1)

For the identification of Hexyl isovalerate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09549

—

Methyl 2-methylvalerate

Additive composition

Methyl 2-methylvalerate

Characterisation of the active substance

Methyl 2-methylvalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H14O2

CAS number 2177-77-7

FLAVIS 09.549

Method of analysis  (1)

For the identification of Methyl 2-methylvalerate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

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

17.1.2017   

EN

Official Journal of the European Union

L 13/80

COMMISSION IMPLEMENTING REGULATION (EU) 2017/54

of 14 December 2016

concerning the authorisation of 2-methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

2-Methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate, herereinafter referred to as ‘the substances concerned’ were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 October 2012 (3) that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that those substances are flavouring agents authorised in food for which the efficacy is demonstrated as the functions of the additive applied for feed use and described for food use are similar.

(5)

The Authority concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the Method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. Maximum recommended contents should be set up for those substances. Those substances may be used within a compound feed subsequently administered via water.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional measures

1.   The substances 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 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 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2012;10(10):2927.

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

2b02001

—

2-Methylpropan-1-ol

Additive composition

2-Methylpropan-1-ol

Characterisation of the active substance

2-Methylpropan-1-ol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C4H10O

CAS number 78-83-1

FLAVIS 02.001

Method of analysis  (1)

For the determination of 2-Methylpropan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b02003

—

Isopentanol

Additive composition

Isopentanol

Characterisation of the active substance

Isopentanol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C5H12O

CAS number 123-51-3

FLAVIS 02.003

Method of analysis  (1)

For the determination of Isopentanol 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b02026

—

3,7-Dimethyloctan-1-ol

Additive composition

3,7-Dimethyloctan-1-ol

Characterisation of the active substance

3,7-Dimethyloctan-1-ol

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C10H22O

CAS number 106-21-8

FLAVIS 02.026

Method of analysis  (1)

For the identification of 3,7-Dimethyloctan-1-ol 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b02082

—

2-Ethylhexan-1-ol

Additive composition

2-Ethylhexan-1-ol

Characterisation of the active substance

2-Ethylhexan-1-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H18O

CAS number 104-76-7

FLAVIS 02.082

Method of analysis  (1)

For the determination of 2-Ethylhexan-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

—

—

—

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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b05004

—

2-Methylpropanal

Additive composition

2-Methylpropanal

Characterisation of the active substance

2-Methylpropanal

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C4H8O

CAS number 78-84-2

FLAVIS 05.004

Method of analysis  (1)

For the determination of 2-Methylpropanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b05006

—

3-Methylbutanal

Additive composition

3-Methylbutanal

Characterisation of the active substance

3-Methylbutanal

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C5H10O

CAS number 590-86-3

FLAVIS 05.006

Method of analysis  (1)

For the determination of 3-Methylbutanal 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b05049

—

2-Methylbutyraldehyde

Additive composition

2-Methylbutyraldehyde

Characterisation of the active substance

2-Methylbutyraldehyde

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C5H10O

CAS number 96-17-3

FLAVIS 05.049

Method of analysis  (1)

For the determination of 2-Methylbutyraldehyde 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08008

—

3-Methylbutyric acid

Additive composition

3-Methylbutyric acid

Characterisation of the active substance

3-Methylbutyric acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C5H10O2

CAS number 503-74-2

FLAVIS 08.008

Method of analysis  (1)

For the determination of 3-Methylbutyric acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08031

—

2-Methylvaleric acid

Additive composition

2-Methylvaleric acid

Characterisation of the active substance

2-Methylvaleric acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H12O2

CAS number 97-61-0

FLAVIS 08.031

Method of analysis  (1)

For the determination of 2-Methylvaleric acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08045

—

2-Ethylbutyric acid

Additive composition

2-Ethylbutyric acid

Characterisation of the active substance

2-Ethylbutyric acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H12O2

CAS number 88-09-5

FLAVIS 08.045

Method of analysis  (1)

For the determination of 2-Ethylbutyric acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08046

—

2-Methylbutyric acid

Additive composition

2-Methylbutyric acid

Characterisation of the active substance

2-Methylbutyric acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C5H10O2

CAS number 116-53-0

FLAVIS 08.046

Method of analysis  (1)

For the determination of 2-Methylbutyric acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08047

—

2-Methylheptanoic acid

Additive composition

2-Methylheptanoic acid

Characterisation of the active substance

2-Methylheptanoic acid

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H16O2

CAS number 1188-02-9

FLAVIS 08.047

Method of analysis  (1)

For the determination of 2-Methylheptanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08062

—

4-Methylnonanoic acid

Additive composition

4-Methylnonanoic acid

Characterisation of the active substance

4-Methylnonanoic acid

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H20O2

CAS number 45019-28-1

FLAVIS 08.062

Method of analysis  (1)

For the identification of 4-Methylnonanoic acid 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b08063

—

4-Methyloctanoic acid

Additive composition

4-Methyloctanoic acid

Characterisation of the active substance

4-Methyloctanoic acid

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C9H18O2

CAS number 54947-74-9

FLAVIS 08.063

Method of analysis  (1)

For the determination of 4-Methyloctanoic acid 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09005

—

Isobutyl acetate

Additive composition

Isobutyl acetate

Characterisation of the active substance

Isobutyl acetate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C6H12O2

CAS number 110-19-0

FLAVIS 09.005

Method of analysis  (1)

For the determination of Isobutyl 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09043

—

Isobutyl butyrate

Additive composition

Isobutyl butyrate

Characterisation of the active substance

Isobutyl butyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H16O2

CAS number 539-90-2

FLAVIS 09.043

Method of analysis  (1)

For the determination of Isobutyl butyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09070

—

3-Methylbutyl hexanoate

Additive composition

3-Methylbutyl hexanoate

Characterisation of the active substance

3-Methylbutyl hexanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H22O2

CAS number 2198-61-0

FLAVIS 09.070

Method of analysis  (1)

For the identification of 3-Methylbutyl hexanoate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09103

—

3-Methylbutyl dodecanoate

Additive composition

3-Methylbutyl dodecanoate

Characterisation of the active substance

3-Methylbutyl dodecanoate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C17H34O2

CAS number 6309-51-9

FLAVIS 09.103

Method of analysis  (1)

For the identification of 3-Methylbutyl dodecanoate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09120

—

3-Methylbutyl octanoate

Additive composition

3-Methylbutyl octanoate

Characterisation of the active substance

3-Methylbutyl octanoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C13H26O2

CAS number 2035-99-6

FLAVIS 09.120

Method of analysis  (1)

For the identification of 3-Methylbutyl 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09136

—

3-Methylbutyl propionate

Additive composition

3-Methylbutyl propionate

Characterisation of the active substance

3-Methylbutyl propionate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H16O2

CAS number 105-68-0

FLAVIS 09.136

Method of analysis  (1)

For the determination of 3-Methylbutyl propionate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09162

—

3-Methylbutyl formate

Additive composition

3-Methylbutyl formate

Characterisation of the active substance

3-Methylbutyl formate

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C6H12O2

CAS number 110-45-2

FLAVIS 09.162

Method of analysis  (1)

For the determination of 3-Methylbutyl formate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09211

—

Glyceryl tributyrate

Additive composition

Glyceryl tributyrate

Characterisation of the active substance

Glyceryl tributyrate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C15H26O6

CAS number 60-01-5

FLAVIS 09.211

Method of analysis  (1)

For the determination of Glyceryl tributyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09417

—

Isobutyl isobutyrate

Additive composition

Isobutyl isobutyrate

Characterisation of the active substance

Isobutyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H16O2

CAS number 97-85-8

FLAVIS 09.417

Method of analysis  (1)

For the determination of Isobutyl isobutyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b09419

—

Isopentyl isobutyrate

Additive composition

Isopentyl isobutyrate

Characterisation of the active substance

Isopentyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H18O2

CAS number 2050-01-3

FLAVIS 09.419

Method of analysis  (1)

For the determination of Isopentyl isobutyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09472

—

Isobutyl isovalerate

Additive composition

Isobutyl isovalerate

Characterisation of the active substance

Isobutyl isovalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H18O2

CAS number 589-59-3

FLAVIS 09.472

Method of analysis  (1)

For the determination of Isobutyl isovalerate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09530

—

Isopentyl 2-methylbutyrate

Additive composition

Isopentyl 2-methylbutyrate

Characterisation of the active substance

Isopentyl 2-methylbutyrate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C10H20O2

CAS number 27625-35-0

FLAVIS 09.530

Method of analysis  (1)

For the determination of Isopentyl 2-methylbutyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09531

—

2-Methylbutyl isovalerate

Additive composition

2-Methylbutyl isovalerate

Characterisation of the active substance

2-Methylbutyl isovalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H20O2

CAS number 2445-77-4

FLAVIS 09.531

Method of analysis  (1)

For the determination of 2-Methylbutyl isovalerate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

6 February 2027

2b09659

—

2-Methylbutyl butyrate

Additive composition

2-Methylbutyl butyrate

Characterisation of the active substance

2-Methylbutyl butyrate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C9H18O2

CAS number 51115-64-1

FLAVIS 09.659

Method of analysis  (1)

For the determination of 2-Methylbutyl butyrate 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.

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 recommended maximum content of the active substance in complete feed shall be indicated.

5.

Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.

6.

For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment

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

17.1.2017   

EN

Official Journal of the European Union

L 13/112

COMMISSION IMPLEMENTING REGULATION (EU) 2017/55

of 14 December 2016

concerning the authorisation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one, isopropyl tetradecanoate as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 October 2015 (3) that, under the proposed conditions of use in feed octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one, isopropyl tetradecanoate do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one, isopropyl tetradecanoate in feed is similar to that on food. The Authority has already concluded that for food those substances are efficacious, as it increases the food smell or palatability. The Authority could not conclude on the safety of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl- hepta-3,5-dien-2-one, nonan-3-one, decan-2-one, isopropyl tetradecanoate used in water for drinking. However, those substances can be used within a compound feed subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount should be indicated on the label of premixtures, compound feeds and feed materials

(6)

The Authority concluded that in the absence of data on user safety, octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl- hepta-3,5-dien- 2-one, nonan-3-one, decan-2-one, isopropyl tetradecanoate should be considered as irritant to skin, eyes and respiratory tract and as a skin sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta- 3,5-dien-2-one, nonan-3-one, decan-2-one, isopropyl tetradecanoate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one, isopropyl tetradecanoate it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2015;13(11):4268.

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

2b02022

—

Octan-2-ol

Additive composition

Octan-2-ol

Characterisation of the active substance

Octan-2-ol

Produced by chemical synthesis

Purity: min 97 %

C8H18O

CAS No 123¬96-6

FLAVIS No:02.022

Methods of Analysis  (1)

For the determination of octan-2-ol 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.

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

2b02079

—

Isopropanol

Additive composition

Isopropanol

Characterisation of the active substance

Isopropanol

Produced by chemical synthesis

Purity: min. 99,7 %

Chemical formula: C3H8O

CAS No 67-63-0

FLAVIS No: 02.079

Method of analysis  (1)

For the determination of isopropanol 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.

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 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: 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.

6 February 2027

2b02088

—

Pentan-2-ol

Additive composition

Pentan-2-ol

Characterisation of the active substance

Pentan-2-ol

Produced by chemical synthesis

Purity: min. 97,9 %

Chemical formula: C5H12O

CAS No 6032-29-7

FLAVIS No: 02.088

Method of analysis  (1)

For the determination of pentan-2-ol 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.

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

2b02098

—

Octan-3-ol

Additive composition

Octan-3-ol

Characterisation of the active substance

Octan-3-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H18O

CAS No 589-98-0

FLAVIS No:02.098

Method of analysis  (1)

For the determination of octan-3-ol 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.

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

2b07002

—

Heptan-2-one

Additive composition

Heptan-2-one

Characterisation of the active substance

Heptan-2-one

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C7H14O

CAS No 110-43-0

FLAVIS No: 07.002

Method of analysis  (1)

For the determination heptan-2-one 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.

The recommended maximum content of the active substance shall be:

for piglets: 4 mg/kg, for chickens for fattening and laying hens: 3 mg/kg, for cats: 2 mg/kg and for other species and categories: 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 %:

—

4 mg/kg for piglets;

—

3 mg/kg for chickens for fattening and laying hens;

—

2 mg/kg for cats;

—

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:

—

4 mg/kg for piglets;

—

3 mg/kg for chickens for fattening and laying hens;

—

2 mg/kg for cats;

—

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

2b07054

—

Pentan-2-one

Additive composition

Pentan-2-one

Characterisation of the active substance

Pentan-2-one

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C5H10O

CAS No 107-87-9

FLAVIS No: 07.054

Method of analysis  (1)

For the determination of pentan-2-one 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.

The recommended maximum content of the active substance shall be:

for piglets: 4 mg/kg, for chickens for fattening and laying hens: 3 mg/kg, for cats: 2 mg/kg and for other species and categories: 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 %:

—

4 mg/kg for piglets;

—

3 mg/kg for chickens for fattening and laying hens;

—

2 mg/kg for cats;

—

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:

—

4 mg/kg for piglets;

—

3 mg/kg for chickens for fattening and laying hens;

—

2 mg/kg for cats;

—

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

2b07099

—

6-Methyl- hepta- 3,5-dien- 2-one

Additive composition

6-Methyl- hepta- 3,5-dien- 2-one

Characterisation of the active substance

6-Methyl- hepta- 3,5-dien- 2-one

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C8H12O

CAS No 1604-28-0

FLAVIS No: 07.099

Method of analysis  (1)

For the determination of 6-methyl- hepta- 3,5-dien- 2-one 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.

The recommended maximum content of the active substance shall be:

for pigs and poultry: 0,3 mg/kg, and for other species and categories: 0,5 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 %:

—

0,3 mg/kg for pigs and poultry;

—

0,5 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:

—

0,3 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.

6 February 2027

2b07113

—

Nonan- 3- one

Additive composition

Nonan- 3- one

Characterisation of the active substance

Nonan- 3- one

Produced by chemical synthesis

Purity: min. 95,9 %

Chemical formula: C9H18O

CAS No 925-78-0

FLAVIS No: 07.113

Method of analysis  (1)

For the determination of nonan- 3- one 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.

The recommended maximum content of the active substance shall be:

pigs and poultry: 0,3 mg/kg, for fish: 0,05 mg/kg and for other species and categories: 0,5 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 %:

—

0,3 mg/kg for pigs and poultry;

—

0,05 mg/kg for fish;

—

0,5 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:

—

0,3 mg/kg for pigs and poultry;

—

0,05 mg/kg for fish;

—

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.

6 February 2027

2b07150

—

Decan- 2 -one

Additive composition

Decan- 2 -one

Characterisation of the active substance

Decan- 2 -one

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H20O

CAS No 693-54-9

FLAVIS No: 07.150

Method of analysis  (1)

For the determination of decan- 2 -one 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.

The recommended maximum content of the active substance shall be:

for pigs and poultry: 0,3 mg/kg, and for other species and categories: 0,5 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 %:

—

0,3 mg/kg for pigs and poultry;

—

0,5 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:

—

0,3 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.

6 February 2027

2b09105

—

Isopropyl tetradecanoate

Additive composition

Isopropyl tetradecanoate

Characterisation of the active substance

Isopropyl tetradecanoate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C17H34O2

CAS No 110-27-0

FLAVIS No 09.105

Method of analysis  (1)

For the determination of isopropyl tetradecanoate 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.

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 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: 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.

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

17.1.2017   

EN

Official Journal of the European Union

L 13/129

COMMISSION IMPLEMENTING REGULATION (EU) 2017/56

of 14 December 2016

concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone (‘the substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 October 2012 (3) that, under the proposed conditions of use in feed the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority is not in a position to evaluate the use of the substances concerned in water for drinking. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and, taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that the substances concerned are considered as potentially hazardous to the respiratory tract skin, eyes and skin sensitisers. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional measures

1.   The substances 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2012;10(10):2928.

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

2b08004

—

Lactic acid

Additive composition

Lactic acid

Characterisation of the active substance

Lactic acid

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C3H6O3

CAS number 598-82-3 and

50-21-5 for DL-lactic acid

79-33-4 for L-lactic acid

FLAVIS No 08.004

Method of analysis  (1)

For the determination of lactic acid 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b08023

—

4-Oxovaleric acid

Additive composition

4-Oxovaleric acid

Characterisation of the active substance

4-Oxovaleric acid

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C5H8O3

CAS number 123-76-2

FLAVIS No 08.023

Method of analysis  (1)

For the determination of 4-oxovaleric acid 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b08024

—

Succinic acid

Additive composition

Succinic acid

Characterisation of the active substance

Succinic acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C4H6O4

CAS number 110-15-6

FLAVIS No 08.024

Method of analysis  (1)

For the determination of succinic acid 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b08025

—

Fumaric acid

Additive composition

Fumaric acid

Characterisation of the active substance

Fumaric acid

Produced by chemical synthesis

Purity: min. 99,5 %

Chemical formula: C4H4O4

CAS number 110-17-8

FLAVIS No 08.025

Method of analysis  (1)

For the determination of fumaric acid 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09402

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Ethyl acetoacetate

Additive composition

Ethyl acetoacetate

Characterisation of the active substance

Ethyl acetoacetate

Produced by chemical synthesis

Purity: min. 97,5 %

Chemical formula: C6H10O3

CAS number 141-97-9

FLAVIS No 09.402

Method of analysis  (1)

For the determination of ethyl acetoacetate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09433

—

Ethyl lactate

Additive composition

Ethyl lactate

Characterisation of the active substance

Ethyl lactate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C5H10O3

CAS number 97-64-3

FLAVIS No 09.433

Method of analysis  (1)

For the determination of ethyl lactate 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.

The recommended maximum content of the active substance shall be: 125 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 %: 125 mg/kg’.

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: 125 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 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 safety glasses and gloves.

6 February 2027

2b09434

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Butyl lactate

Additive composition

Butyl lactate

Characterisation of the active substance

Butyl lactate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C7H14O3

CAS number 138-22-7

FLAVIS No 09.434

Method of analysis  (1)

For the determination of butyl lactate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09435

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Ethyl 4-oxovalerate

Additive composition

Ethyl 4-oxovalerate

Characterisation of the active substance

Ethyl 4-oxovalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H12O3

CAS number 539-88-8

FLAVIS No 09.435

Method of analysis  (1)

For the determination of ethyl 4-oxovalerate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09444

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Diethyl succinate

Additive composition

Diethyl succinate

Characterisation of the active substance

Diethyl succinate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H14O4

CAS number 123-25-1

FLAVIS No 09.444

Method of analysis  (1)

For the determination of diethyl succinate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09490

—

Diethyl malonate

Additive composition

Diethyl malonate

Characterisation of the active substance

Diethyl malonate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C7H12O4

CAS number 105-53-3

FLAVIS No 09.490

Method of analysis  (1)

For the determination of diethyl malonate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09491

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Butyl-O-butyryllactate

Additive composition

Butyl-O-butyryllactate

Characterisation of the active substance

Butyl-O-butyryllactate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C11H20O4

CAS number 7492-70-8

FLAVIS No 09.491

Method of analysis  (1)

For the determination of butyl-O-butyryllactate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09545

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Hex-3-enyl lactate

Additive composition

Hex-3-enyl lactate

Characterisation of the active substance

Hex-3-enyl lactate

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C9H16O3

CAS number 61931-81-5

FLAVIS No 09.545

Method of analysis  (1)

For the determination of hex-3-enyl lactate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09580

—

Hexyl lactate

Additive composition

Hexyl lactate

Characterisation of the active substance

Hexyl lactate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C9H18O3

CAS number 20279-51-0

FLAVIS No 09.580

Method of analysis  (1)

For the determination of hexyl lactate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10006

—

Butyro-1,4-lactone

Additive composition

Butyro-1,4-lactone

Characterisation of the active substance

Butyro-1,4-lactone

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C4H6O2

CAS number 96-48-0

FLAVIS No 10.006

Method of analysis  (1)

For the determination of butyro-1,4-lactone 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10007

—

Decano-1,5-lactone

Additive composition

Decano-1,5-lactone

Characterisation of the active substance

Decano-1,5-lactone

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H18O2

CAS number 705-86-2

FLAVIS No 10.007

Method of analysis  (1)

For the determination of decano-1,5-lactone 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10011

—

Undecano-1,5-lactone

Additive composition

Undecano-1,5-lactone

Characterisation of the active substance

Undecano-1,5-lactone

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H20O2

CAS number 710-04-3

FLAVIS No 10.011

Method of analysis  (1)

For the determination of undecano-1,5-lactone 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10013

—

Pentano-1,4-lactone

Additive composition

Pentano-1,4-lactone

Characterisation of the active substance

Pentano-1,4-lactone

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C5H8O2

CAS number 108-29-2

FLAVIS No 10.013

Method of analysis  (1)

For the determination of pentano-1,4-lactone 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10014

—

Nonano-1,5-lactone

Additive composition

Nonano-1,5-lactone

Characterisation of the active substance

Nonano-1,5-lactone

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H16O2

CAS number 3301-94-8

FLAVIS No 10.014

Method of analysis  (1)

For the determination of nonano-1,5-lactone 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10015

—

Octano-1,5-lactone

Additive composition

Octano-1,5-lactone

Characterisation of the active substance

Octano-1,5-lactone

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H14O2

CAS number 698-76-0

FLAVIS No 10.015

Method of analysis  (1)

For the determination of octano-1,5-lactone 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10020

—

Heptano-1,4-lactone

Additive composition

Heptano-1,4-lactone

Characterisation of the active substance

Heptano-1,4-lactone

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H12O2

CAS number 105-21-5

FLAVIS No 10.020

Method of analysis  (1)

For the determination of heptano-1,4-lactone 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b10021

—

Hexano-1,4-lactone

Additive composition

Hexano-1,4-lactone

Characterisation of the active substance

Hexano-1,4-lactone

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H10O2

CAS number 695-06-7

FLAVIS No 10.021

Method of analysis  (1)

For the determination of hexano-1,4-lactone 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.

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 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: 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 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 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

17.1.2017   

EN

Official Journal of the European Union

L 13/153

COMMISSION IMPLEMENTING REGULATION (EU) 2017/57

of 14 December 2016

concerning the authorisation of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

1,8-Cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 6 March 2012 and 13 November 2012 (3) that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran in feed is similar to that on food. The Authority has already concluded that for food those substances are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. As the use of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran in water for drinking is difficult to control when used simultaneously with feed, such use should be excluded. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran are irritant to eyes, respiratory tract and skin. The Authority further concluded that 3,4-dihydrocoumarin is also skin sensitiser and harmful if swallowed. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2012;10(3):2622 and EFSA Journal 2012;10(11):2967

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

2b03001

—

1,8-Cineole

Additive composition

1,8-Cineole

Characterisation of the active substance

1,8-Cineole

Produced by distillation from Eucalyptus globulus

Purity: min. 98 %

Chemical formula: C10H18O

CAS number 470-82-6

FLAVIS No 03.001

Method of analysis  (1)

For the determination of 1,8-cineole 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.

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 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: 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.

6 February 2027

2b13009

—

3,4-Dihydrocoumarin

Additive composition

3,4-Dihydrocoumarin

Characterisation of the active substance

3,4-Dihydrocoumarin

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C9H8O2

CAS number 119-84-6

FLAVIS No 13.009

Method of analysis  (1)

For the determination of 3,4-dihydrocoumarin 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.

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 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: 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.

6 February 2027

2b13037

—

2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran

Additive composition

2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran

Characterisation of the active substance

2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C10H18O

CAS number 16409-43-1

FLAVIS No 13.037

Method of analysis  (1)

For the identification of 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran 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: 0,5 mg/kg, and for other species and categories: 0,3 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 %:

—

0,5 mg/kg for pigs and poultry;

—

0,3 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:

—

0,5 mg/kg for pigs and poultry;

—

0,3 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

17.1.2017   

EN

Official Journal of the European Union

L 13/159

COMMISSION IMPLEMENTING REGULATION (EU) 2017/58

of 14 December 2016

concerning the authorisation of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 November 2012 (3) that, under the proposed conditions of use in feed of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate in feed is similar to that on food. The Authority has already concluded that for food alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate are efficacious, as it increases the food smell or palatability. The Authority concluded that for nerolidol and 2-(4-methylphenyl) propan-2-ol the absence of margin of safety would not allow simultaneous administration in feed and water. For alpha-terpineol, terpineol and linalyl acetate the exact ratio for the inclusion in feed and water is not available. However, those substances can be used within a compound feed subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that in the absence of data on user safety alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate should be considered as irritant to skin, eyes and respiratory tract and as a skin sensitizer. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2012;10(11):2966.

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

2b02014

—

alpha-Terpineol

Additive composition

alpha-Terpineol

Characterisation of the active substance

alpha-Terpineol

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C10H18O

CAS No 98-55-5

FLAVIS No: 02.014

Method of analysis  (1)

For the determination of alpha-Terpineol 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.

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 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: 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.

6 February 2027

2b02018

—

Nerolidol

Additive composition

Nerolidol

Characterisation of the active substance

Nerolidol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C15H26O

CAS No 7212-44-4

FLAVIS No: 02.018

Method of analysis  (1)

For the identification of Nerolidol 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

2b02042

—

2-(4-Methylphenyl)propan-2-ol

Additive composition

2-(4-Methylphenyl)propan-2-ol

Characterisation of the active substance

2-(4-Methylphenyl)propan-2-ol

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C10H14O

CAS No 1197-01-9

FLAVIS No: 02.042

Method of analysis  (1)

For the identification of 2-(4-Methylphenyl)propan-2-ol 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 all 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

2b02230

—

Terpineol

Additive composition

Terpineol

Characterisation of the active substance

Terpineol

Produced by chemical synthesis

Purity: min. 91 %

Chemical formula: C10H18O

CAS No 8000-41-7

FLAVIS No: 02.230

Method of analysis  (1)

For the determination of Terpineol 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.

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 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: 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.

6 February 2027

2b09013

—

Linalyl acetate

Additive composition

Linalyl acetate

Characterisation of the active substance

Linalyl acetate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C12H20O2

CAS No 115-95-7

FLAVIS No: 09.013

Method of analysis  (1)

For the determination of Linalyl 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.

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 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: 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.

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

17.1.2017   

EN

Official Journal of the European Union

L 13/167

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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

1,1-Dimethoxy-2-phenylethane, phenethyl formate, phenethyl octanoate, phenethyl isobutyrate, phenethyl 2-methyl-butyrate and phenethyl benzoate (‘the substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feeds additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 March 2012 (3) that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food those substances are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. As the use of the substances concerned in water for drinking is difficult to control when used simultaneously with feed such use should be excluded. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that the substances concerned are considered as irritant to eyes and respiratory tract, skin sensitisers and harmful if swallowed. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2012;10(3):2625.

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: C10H14O2

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: C9H10O2

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: C16H24O2

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: C12H16O2

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: C13H18O2

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: C15H14O2

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

17.1.2017   

EN

Official Journal of the European Union

L 13/177

COMMISSION IMPLEMENTING REGULATION (EU) 2017/60

of 14 December 2016

concerning the authorisation of isoeugenol as a feed additive for pigs, ruminants and horses except those producing milk for human consumption and pets

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Isoeugenol, was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the isoeugenol as a feed additive for all animal species except for poultry, ruminants producing milk for human consumption and fish. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 December 2011 (3) that, under the proposed conditions of use in feed, isoeugenol does not have adverse effects on animal health, human health or the environment. Isoeugenol should not be allowed for those categories of mammal species intended for the production of milk for human consumption. The Authority further concluded that the function of isoeugenol in feed is similar to that on food. The Authority has already concluded that for food isoeugenol is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority concluded that the simultaneous use in feed and water for drinking should be avoided. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that isoeugenol is an irritant to the respiratory tract, skin and eyes and it is also a skin and respiratory sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of the substance concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for that substance it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, 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 substance 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 substance 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2012;10(1):2532.

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

2b04004

—

Isoeugenol

Additive composition

Isoeugenol

Characterisation of the active substance

Isoeugenol

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C10H12O2

CAS number 97-54-1

FLAVIS No 04.004

Method of analysis  (1)

For the identification of isoeugenol in the feed additive and flavouring premixtures:

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

Pigs

Ruminants and horses except those producing milk for human consumption

Pets

—

—

—

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:

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 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: 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 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 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

17.1.2017   

EN

Official Journal of the European Union

L 13/181

COMMISSION IMPLEMENTING REGULATION (EU) 2017/61

of 14 December 2016

concerning the authorisation of 4-allyl-2,6-dimethoxyphenol and eugenyl acetate as feed additives for all animal species except for fish and poultry

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

4-Allyl-2,6-dimethoxyphenol and eugenyl acetate were authorised without a time limit in accordance with Directive 70/524/EEC as feeds additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. 4-Allyl-2,6-dimethoxyphenol and eugenyl acetate for poultry and fish will not be re-authorised as they were withdrawn by the applicant.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of 4-allyl-2,6-dimethoxyphenol and eugenyl acetate as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 November 2011 (3) that, under the proposed conditions of use in feed, 4-allyl-2,6-dimethoxyphenol and eugenyl acetate do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of 4-allyl-2,6-dimethoxyphenol and eugenyl acetate in feed is similar to that on food. The Authority has already concluded that for food those substances are efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority is not in a position to evaluate the use 4-allyl-2,6-dimethoxyphenol and eugenyl acetate in water for drinking. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that 4-allyl-2,6-dimethoxyphenol is irritant to eyes and skin and that eugenyl acetate is irritant to skin only. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of 4-allyl-2,6-dimethoxyphenol and eugenyl acetate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for 4-allyl-2,6-dimethoxyphenol and eugenyl acetate, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional measures

1.   The substances 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2011;9(12):2440.

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

2b04051

—

4-Allyl-2,6-dimethoxyphenol

Additive composition

4-Allyl-2,6-dimethoxyphenol

Characterisation of the active substance

4-Allyl-2,6-dimethoxyphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H14O3

CAS number 6627-88-9

FLAVIS No 04.051

Method of analysis  (1)

For the identification of 4-allyl-2,6-dimethoxyphenol in the feed additive and flavouring premixtures:

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

All animal speciesexcept fish and poultry)

—

—

—

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: 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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09020

—

Eugenyl acetate

Additive composition

Eugenyl acetate

Characterisation of the active substance

Eugenyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H14O3

CAS number 93-28-7

FLAVIS No 09.020

Method of analysis  (1)

For the identification of eugenyl acetate in the feed additive and flavouring premixtures:

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

All animal species except fish and poultry.

—

—

—

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: 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 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: 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 dermal 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 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

17.1.2017   

EN

Official Journal of the European Union

L 13/186

COMMISSION IMPLEMENTING REGULATION (EU) 2017/62

of 14 December 2016

concerning the authorisation of 3-(methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

3-(Methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane (‘the substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 April 2013 (3) that, under the proposed conditions of use in feed the substances concerned do not have adverse effects on animal health, human health or the environment. For allyl isothiocyanate, the Authority stated that, although additional exposure to that substance through its low use level in animal feeds would not substantially increase consumer exposure, the estimated exposure of consumers is already higher than the acceptable daily intake. For allyl isothiocyanate and 2-methylpropane-1-thiol maximum contents should be set up to ensure consumer safety and environmental protection, respectively. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority could not conclude on the safety of the substances concerned used in water for drinking. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. For all the substances except allyl isothiocyanate and 2-methylpropane-1-thiol, since safety reasons do not require the setting of a maximum content and, taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that the substances concerned are to be considered as being irritant to skin, eyes and respiratory tract and as a skin sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional measures

1.   The substances 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2013;11(5):3208.

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

2b12001

—

3-(Methylthio)propionaldehyde

Additive composition

3-(Methylthio) propionaldehyde

Characterisation of the active substance

3-(Methylthio) propionaldehyde

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C4H8OS

CAS number 3268-49-3

FLAVIS No 12.001

Method of analysis  (1)

For the determination of 3-(methylthio) propionaldehyde 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12002

—

Methyl 3-(methylthio)propionate

Additive composition

Methyl 3-(methylthio)propionate

Characterisation of the active substance

Methyl 3-(methylthio)propionate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C5H10O2S

CAS number 13532-18-8

FLAVIS No 12.002

Method of analysis  (1)

For the determination of methyl 3-(methylthio)propionate 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12004

—

Allylthiol

Additive composition

Allylthiol

Characterisation of the active substance

Allylthiol

Produced by chemical synthesis

Purity: min. 75 % (min. 98 % allylthiol + allyl sulphide + allyl mercaptan)

Chemical formula: C3H6S

CAS number 870-23-5

FLAVIS No 12.004

Method of analysis  (1)

For the determination of allylthiol 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12006

—

Dimethyl sulfide

Additive composition

Dimethyl sulfide

Characterisation of the active substance

Dimethyl sulfide

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C2H6S

CAS number 75-18-3

FLAVIS No 12.006

Method of analysis  (1)

For the determination of dimethyl 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12007

—

Dibutyl sulfide

Additive composition

Dibutyl sulfide

Characterisation of the active substance

Dibutyl sulfide

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C8H18S

CAS number 544-40-1

FLAVIS No 12.007

Method of analysis  (1)

For the determination of dibutyl 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12008

—

Diallyl disulfide

Additive composition

Diallyl disulfide

Characterisation of the active substance

Diallyl disulfide

Produced by chemical synthesis

Purity: min. 80 % (min. 98 % diallyl disulphide +allyl sulphide + allyl mercaptan)

Chemical formula: C6H10S2

CAS number 2179-57-9

FLAVIS No 12.008

Method of analysis  (1)

For the determination of diallyl 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12009

—

Diallyl trisulfide

Additive composition

Diallyl trisulfide

Characterisation of the active substance

Diallyl trisulfide

Produced by chemical synthesis

Purity: min. 65 % (min.95 % allyl di-, tri- and tetra sulfides)

Chemical formula: C6H10S3

CAS number 2050-87-5

FLAVIS No 12.009

Method of analysis  (1)

For the determination of diallyl trisulfide 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12013

—

Dimethyl trisulfide

Additive composition

Dimethyl trisulfide

Characterisation of the active substance

Dimethyl trisulfide

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C2H6S3

CAS number 3658-80-8

FLAVIS No 12.013

Method of analysis  (1)

For the determination of dimethyl trisulfide 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12014

—

Dipropyl disulfide

Additive composition

Dipropyl disulfide

Characterisation of the active substance

Dipropyl disulfide

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H14S2

CAS number 629-19-6

FLAVIS No 12.014

Method of analysis  (1)

For the determination of dipropyl 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12025

—

Allyl isothiocyanate

Additive composition

Allyl isothiocyanate

Characterisation of the active substance

Allyl isothiocyanate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C4H5NS

CAS number 57-06-7

FLAVIS No 12.025

Method of analysis  (1)

For the identification of allyl isothiocyanate in the feed additive and flavouring premixtures:

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

All animal species

—

—

0,05

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.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.

6 February 2027

2b12026

—

Dimethyl disulfide

Additive composition

Dimethyl disulfide

Characterisation of the active substance

Dimethyl disulfide

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C2H6S2

CAS number 624-92-0

FLAVIS No 12.026

Method of analysis  (1)

For the determination of dimethyl 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12027

—

2-Methylbenzene-1-thiol

Additive composition

2-Methylbenzene-1-thiol

Characterisation of the active substance

2-Methylbenzene-1-thiol

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C7H8S

CAS number 137-06-4

FLAVIS No 12.027

Method of analysis  (1)

For the determination of 2-methylbenzene-1-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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12032

—

S-Methyl butanethioate

Additive composition

S-Methyl butanethioate

Characterisation of the active substance

S-Methyl butanethioate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C5H10OS

CAS number 2432-51-1

FLAVIS No 12.032

Method of analysis  (1)

For the determination of S-methyl butanethioate 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12037

—

Allyl methyl disulfide

Additive composition

Allyl methyl disulfide

Characterisation of the active substance

Allyl methyl disulfide

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C4H8S2

CAS number 2179-58-0

FLAVIS No 12.037

Method of analysis  (1)

For the determination of allyl methyl 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12062

—

3-(Methylthio)propan-1-ol

Additive composition

3-(Methylthio)propan-1-ol

Characterisation of the active substance

3-(Methylthio)propan-1-ol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C4H10OS

CAS number 505-10-2

FLAVIS No 12.062

Method of analysis  (1)

For the determination of 3-(methylthio)propan-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

—

—

—

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: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12063

—

3-(Methylthio)hexan-1-ol

Additive composition

3-(Methylthio)hexan-1-ol

Characterisation of the active substance

3-(Methylthio)hexan-1-ol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C7H16OS

CAS number 51755-66-9

FLAVIS No 12.063

Method of analysis  (1)

For the determination of 3-(methylthio)hexan-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

—

—

—

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: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12071

—

1-Propane-1-thiol

Additive composition

1-Propane-1-thiol

Characterisation of the active substance

1-Propane-1-thiol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C3H8S

CAS number 107-03-9

FLAVIS No 12.071

Method of analysis  (1)

For the determination of 1-propane-1-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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12088

—

Diallyl sulfide

Additive composition

Diallyl sulfide

Characterisation of the active substance

Diallyl sulfide

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C6H10S

CAS number 592-88-1

FLAVIS No 12.088

Method of analysis  (1)

For the determination of diallyl 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12118

—

2,4-Dithiapentane

Additive composition

2,4-Dithiapentane

Characterisation of the active substance

2,4-Dithiapentane

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C3H8S2

CAS number 1618-26-4

FLAVIS No 12.118

Method of analysis  (1)

For the determination of 2,4-dithiapentane 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12168

—

2-Methyl-2-(methyldithio) propanal

Additive composition

2-Methyl-2-(methyldithio)propanal

Characterisation of the active substance

2-Methyl-2-(methyldithio)propanal

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C5H10OS2

CAS number 67952-60-7

FLAVIS No 12.168

Method of analysis  (1)

For the determination of 2-methyl-2-(methyldithio) propanal 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12173

—

2-Methylpropane-1-thiol

Additive composition

2-Methylpropane-1-thiol

Characterisation of the active substance

2-Methylpropane-1-thiol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C4H10S

CAS number 513-44-0

FLAVIS No 12.173

Method of analysis  (1)

For the identification of 2-methylpropane-1-thiol in the feed additive and flavouring premixtures:

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

All animal species

—

—

0,04

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.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.

6 February 2027

2b12175

—

Methylsulfinyl methane

Additive composition

Methylsulfinylmethane

Characterisation of the active substance

Methylsulfinylmethane

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C2H6OS

CAS number 67-68-5

FLAVIS No 12.175

Method of analysis  (1)

For the determination of methylsulfinylmethane 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b12197

—

Propane-2-thiol

Additive composition

Propane-2-thiol

Characterisation of the active substance

Propane-2-thiol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C3H8S

CAS number 75-33-2

FLAVIS No 12.197

Method of analysis  (1)

For the determination of propane-2-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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b15025

—

3,5-Dimethyl-1,2,4-trithiolane

Additive composition

3,5-Dimethyl-1,2,4-trithiolane

Characterisation of the active substance

3,5-Dimethyl-1,2,4-trithiolane

Produced by chemical synthesis

Purity: min. 90 %

Secondary components: diethyl trisulphide, dimethylbenzylcarbinol, N,N-dimethyl-ethanethioamide, 4,6-dimethyl1,2,3,5-tetracyclohexane, 3-methyl-1,2,4-trithiolane, 2-methyl-4-propyl 1,3-oxathiane

Chemical formula: C4H8S3

CAS number 23654-92-4

FLAVIS No 15.025

Method of analysis  (1)

For the determination of 3,5-dimethyl-1,2,4-trithiolane 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 safety glasses and gloves.

6 February 2027

2b16030

—

2-Methyl-4-propyl-1,3-oxathiane

Additive composition

2-Methyl-4-propyl-1,3-oxathiane

Characterisation of the active substance

2-Methyl-4-propyl-1,3-oxathiane

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H16OS

CAS number 67715-80-4

FLAVIS No 16.030

Method of analysis  (1)

For the determination of 2-methyl-4-propyl-1,3-oxathiane 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.

The recommended maximum content of the active substance shall be: 0,05 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 %: 0,05 mg/kg’.

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: 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 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 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

17.1.2017   

EN

Official Journal of the European Union

L 13/214

COMMISSION IMPLEMENTING REGULATION (EU) 2017/63

of 14 December 2016

concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, veratraldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, gallic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate (‘substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. Veratraldehyde for poultry and fish and gallic acid for fish will not be re-authorised as they were withdrawn by the applicant.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority cannot conclude on the safety of the concerned substances in water for drinking. However, those substances can be used within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content, except for benzoic acid, and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that in the absence of data the substances concerned should be considered as potentially hazardous to the respiratory tract, skin and eyes, skin sensitisers and harmful if swallowed. Consequently, appropriate protective measures should be taken The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional measures

1.   The substances 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2012;10(7):2785.

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

2b02010

—

Benzyl alcohol

Additive composition

Benzyl alcohol

Characterisation of the active substance

Benzyl alcohol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H8O

CAS number 100-51-6

FLAVIS No 02.010

Method of analysis  (1)

For the determination of benzyl 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.

The recommended maximum content of the active substance shall be: 125 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 %: 125 mg/kg’.

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: 125 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 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 safety glasses and gloves.

6 February 2027

2b02039

—

4-Isopropylbenzyl alcohol

Additive composition

4-Isopropylbenzyl alcohol

Characterisation of the active substance

4-Isopropylbenzyl alcohol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C10H14O

CAS number 536-60-7

FLAVIS No 02.039

Method of analysis  (1)

For the determination of 4-isopropylbenzyl 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b05013

—

Benzaldehyde

Additive composition

Benzaldehyde

Characterisation of the active substance

Benzaldehyde

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H6O

CAS number 100-52-7

FLAVIS No 05.013

Method of analysis  (1)

For the determination of benzaldehyde 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b05017

—

Veratraldehyde

Additive composition

Veratraldehyde

Characterisation of the active substance

Veratraldehyde

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C9H10O3

CAS number 120-14-9

FLAVIS No 05.017

Method of analysis  (1)

For the identification of veratraldehyde in the feed additive and flavouring premixtures.

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

All animal species except poultry and fish

—

—

—

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: 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 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: 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 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 safety glasses and gloves.

6 February 2027

2b05022

—

4-Isopropylbenzaldehyde

Additive composition

4-Isopropylbenzaldehyde

Characterisation of the active substance

4-Isopropylbenzaldehyde

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C10H12O

CAS number 122-03-2

FLAVIS No 05.022

Method of analysis  (1)

For the determination of 4-isopropylbenzaldehyde 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b05055

—

Salicylaldehyde

Additive composition

Salicylaldehyde

Characterisation of the active substance

Salicylaldehyde

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C7H6O2

CAS number 90-02-8

FLAVIS No 05.055

Method of analysis  (1)

For the identification of salicylaldehyde 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: 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 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.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.

6 February 2027

2b05029

—

p-Tolualdehyde

Additive composition

p-Tolualdehyde

Characterisation of the active substance

p-Tolualdehyde

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H8O

CAS number 104-87-0

FLAVIS No 05.029

Method of analysis  (1)

For the determination of p-tolualdehyde 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b05129

—

2-Methoxybenzaldehyde

Additive composition

2-Methoxybenzaldehyde

Characterisation of the active substance

2-Methoxybenzaldehyde

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H8O2

CAS number 135-02-4

FLAVIS No 05.129

Method of analysis  (1)

For the identification of 2-methoxybenzaldehyde 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: 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 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.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.

6 February 2027

2b08021

—

Benzoic acid

Additive composition

Benzoic acid

Characterisation of the active substance

Benzenecarboxylic acid, phenylcarboxylic acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C7H6O2

CAS number 65-85-0

FLAVIS No 08.021

Maximum level of impurities

Phthalic acid: ≤ 100 mg/kg;

Biphenyl: ≤ 100 mg/kg

Method of analysis  (1)

For the determination of benzoic acid in the feed additive and in feed flavouring premixtures.

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

All animal species

—

—

125

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.

For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalatory or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08080

—

Gallic acid

Additive composition

Gallic acid

Characterisation of the active substance

Gallic acid

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C7H6O5

CAS number 149-91-7

FLAVIS No 08.080

Method of analysis  (1)

For the identification of gallic acid in the feed additive and flavouring premixtures.

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

All animal species except fish

—

—

—

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: 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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09014

—

Benzyl acetate

Additive composition

Benzyl acetate

Characterisation of the active substance

Benzyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H10O2

CAS number 140-11-4

FLAVIS No 09.014

Method of analysis  (1)

For the determination of benzyl 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.

The recommended maximum content of the active substance shall be: 125 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 %: 125 mg/kg’.

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: 125 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 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 safety glasses and gloves.

6 February 2027

2b09051

—

Benzyl butyrate

Additive composition

Benzyl butyrate

Characterisation of the active substance

Benzyl butyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H14O2

CAS number 103-37-7

FLAVIS No 09.051

Method of analysis  (1)

For the determination of benzyl butyrate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09077

—

Benzyl formate

Additive composition

Benzyl formate

Characterisation of the active substance

Benzyl formate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C8H8O2

CAS number 104-57-4

FLAVIS No 09.077

Method of analysis  (1)

For the determination of benzyl formate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09132

—

Benzyl propionate

Additive composition

Benzyl propionate

Characterisation of the active substance

Benzyl propionate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H12O2

CAS number 122-63-4

FLAVIS No 09.132

Method of analysis  (1)

For the determination of benzyl propionate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09316

 

Benzyl hexanoate

Additive composition

Benzyl hexanoate

Characterisation of the active substance

Benzyl hexanoate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C13H18O2

CAS number 6938-45-0

FLAVIS No 09.316

Method of analysis  (1)

For the identification of benzyl hexanoate 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 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 safety glasses and gloves.

6 February 2027

2b09426

—

Benzyl isobutyrate

Additive composition

Benzyl isobutyrate

Characterisation of the active substance

Benzyl isobutyrate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C11H14O2

CAS number 103-28-6

FLAVIS No 09.426

Method of analysis  (1)

For the determination of benzyl isobutyrate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09458

—

Benzyl isovalerate

Additive composition

Benzyl isovalerate

Characterisation of the active substance

Benzyl isovalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H16O2

CAS number 103-38-8

FLAVIS No 09.458

Method of analysis  (1)

For the determination of benzyl isovalerate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09581

—

Hexyl salicylate

Additive composition

Hexyl salicylate

Characterisation of the active substance

Hexyl salicylate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C13H18O3

CAS number 6259-76-3

FLAVIS No 09.581

Method of analysis  (1)

For the identification of hexyl salicylate 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: 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 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.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.

6 February 2027

2b09705

—

Benzyl phenylacetate

Additive composition

Benzyl phenylacetate

Characterisation of the active substance

Benzyl phenylacetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C15H14O2

CAS number 102-16-9

FLAVIS No 09.705

Method of analysis  (1)

For the determination of benzyl phenylacetate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09725

—

Methyl benzoate

Additive composition

Methyl benzoate

Characterisation of the active substance

Methyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H8O2

CAS number 93-58-3

FLAVIS No 09.725

Method of analysis  (1)

For the determination of methyl benzoate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09726

—

Ethyl benzoate

Additive composition

Ethyl benzoate

Characterisation of the active substance

Ethyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H10O2

CAS number 93-89-0

FLAVIS No 09.726

Method of analysis  (1)

For the determination of ethyl benzoate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09755

—

Isopentyl benzoate

Additive composition

Isopentyl benzoate

Characterisation of the active substance

Isopentyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H16O2

CAS number 94-46-2

FLAVIS No 09.755

Method of analysis  (1)

For the determination of isopentyl benzoate 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.

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 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: 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 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 safety glasses and gloves.

6 February 2027

2b09762

—

Pentyl salicylate

Additive composition

Pentyl salicylate

Characterisation of the active substance

Pentyl salicylate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula C12H16O3

CAS number 2050-08-0

FLAVIS No 09.762

Method of analysis  (1)

For the identification of pentyl salicylate 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: 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 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.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.

6 February 2027

2b09757

—

Isobutyl benzoate

Additive composition

Isobutyl benzoate

Characterisation of the active substance

Isobutyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H14O2

CAS number 120-50-3

FLAVIS No 09.757

Method of analysis  (1)

For the determination of isobutyl benzoate 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.

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 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: 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 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 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

17.1.2017   

EN

Official Journal of the European Union

L 13/242

COMMISSION IMPLEMENTING REGULATION (EU) 2017/64

of 14 December 2016

concerning the authorisation of glycyrrhizic acid ammoniated as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Glycyrrhizic acid ammoniated was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of glycyrrhizic acid ammoniated as a feed additive for all animal species. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 December 2014 (3) that, under the proposed conditions of use in feed glycyrrhizic acid ammoniated does not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of glycyrrhizic acid ammoniated in feed is similar to that on food. The Authority has already concluded that for food glycyrrhizic acid ammoniated is efficacious, as it increases the food smell or palatability. The Authority could not conclude on the safety of for glycyrrhizic acid ammoniated used in water for drinking. However, that substance can be used within a compound feed subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that in the absence of data on user safety glycyrrhizic acid ammoniated should be considered as irritant to skin, eyes and respiratory tract and as a skin sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of glycyrrhizic acid ammoniated shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for glycyrrhizic acid ammoniated, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, 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 substance 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 substance 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2015;13(1):3971.

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

2b16060

—

Glycyrrhizic acid ammoniated

Additive composition

Glycyrrhizic acid ammoniated

Characterisation of the active substance

Glycyrrhizic acid ammoniated

Produced by extraction of species of the genus Glycyrrhiza

Purity: min. 98-100 % (on dry matter basis)

Chemical formula: C42H65O16

CAS No 53956-04-0

FLAVIS No: 16.060

Method of analysis  (1)

For the identification of the glycyrrhizic acid ammoniated in the feed additive and flavouring premixtures:

European Pharmacopeian 6.0, method 01/2008:1772.

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 %:

—

0,3 mg/kg for chickens for fattening and laying hens,

—

1 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 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:

—

0,3 mg/kg for chickens for fattening and laying hens,

—

1 mg/kg for other species and categories.

5.

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

17.1.2017   

EN

Official Journal of the European Union

L 13/246

COMMISSION IMPLEMENTING REGULATION (EU) 2017/65

of 14 December 2016

concerning the authorisation of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

1-Isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene, were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions (3) of 10 March 2015 and of 1 December 2015 that, under the proposed conditions of use in feed 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene in feed is similar to that on food. The Authority has already concluded that for food 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene are efficacious, as it increases the food smell or palatability. The Authority could not conclude on the safety of for pin-2(3)-ene, pin-2(10)-ene, delta-3-carene, beta-caryophyllene and camphene used in water for drinking. The Authority concluded that for d-limonene, 1-isopropyl-4-methylbenzene and 1-isopropenyl-4-methylbenzene the absence of margin of safety would not allow simultaneous administration in feed and water. However, those substances can be used within a compound feed subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that in the absence of data on user safety 1-Isopropyl- 4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene should be considered as irritant to skin, eyes and respiratory tract and as a skin sensitiser. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for 1-isopropyl- 4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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 2

Transitional 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2015;13(3):4053 and EFSA Journal 2016;14(1):4339

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

2b01002

—

1-Isopropyl-4-methylbenzene

Additive composition

1-Isopropyl-4-methylbenzene

Characterisation of the active substance

1-Isopropyl-4-methylbenzene

Produced by chemical synthesis

Purity: min 97 %

C10H14

CAS No 99¬87-6

FLAVIS No: 01.002

Method of analysis  (1)

For the determination of 1-isopropyl-4-methylbenzene 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.

The recommended maximum content of the active substance shall be:

For cats: 14 mg/kg, and for other species and categories: 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 %:

—

14 mg/kg for cats;

—

25 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:

—

14 mg/kg for cats;

—

25 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 eye 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

2b01003

—

Pin-2(10)-ene

Additive composition

Pin-2(10)-ene

Characterisation of the active substance

Pin-2(10)-ene

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C10H16

CAS No 127-91-3

FLAVIS No: 01.003

Method of analysis  (1)

For the determination of pin-2(10)-ene 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.

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 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: 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 eye 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

2b01004

—

Pin-2(3)-ene

Additive composition

Pin-2(3)-ene

Characterisation of the active substance

Pin-2(3)-ene

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C10H16

CAS No 80-56-8

FLAVIS No: 01.004

Method of analysis  (1)

For the determination of pin-2(3)-ene 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.

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 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: 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 eye 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

2b01007

—

beta-caryophyllene

Additive composition

beta-caryophyllene

Characterisation of the active substance

beta-caryophyllene

Produced by chemical synthesis

Purity: min. 80 %

Chemical formula: C15H24

CAS No 87-44-5

FLAVIS No: 01.007

Method of analysis  (1)

For the determination of beta-caryophyllene 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.

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 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: 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 eye 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

2b01009

—

Camphene

Additive composition

Camphene

Characterisation of the active substance

Camphene

Produced by chemical synthesis

Purity: min. 80 %

Chemical formula: C10H16

CAS No 79-92-5

FLAVIS No: 01.009

Method of analysis  (1)

For the determination of camphene 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.

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 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: 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 eye 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

2b01010

—

1-Isopropenyl-4-methylbenzene

Additive composition

1-Isopropenyl-4-methylbenzene

Characterisation of the active substance

1-Isopropenyl-4-methylbenzene

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C10H12

CAS No 1195-32-0

FLAVIS No:01.010

Method of analysis  (1)

For the determination of 1-Isopropenyl-4-methylbenzene 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.

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 eye 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

2b01029

—

delta-3-Carene

Additive composition

delta-3-Carene

Characterisation of the active substance

delta-3-Carene

Produced by chemical synthesis

Purity: min. 92 %

Chemical formula: C10H16

CAS No 13466-78-9

FLAVIS No:01.029

Method of analysis  (1)

For the determination of delta-3-Carene 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.

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 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: 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 eye 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

2b01045

—

d-Limonene

Additive composition

d-Limonene

Characterisation of the active substance

d-Limonene

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C10H16

CAS No 5989-27-5

FLAVIS No: 01.045

Method of analysis  (1)

For the determination of d-limonene in the feed additive and in feed flavouring premixtures:

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

All animal species except male rats

—

—

—

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 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 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: 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 eye 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

17.1.2017   

EN

Official Journal of the European Union

L 13/259

COMMISSION IMPLEMENTING REGULATION (EU) 2017/66

of 14 December 2016

concerning the authorisation of tannic acid as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Tannic acid was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of tannic acid as a feed additive for all animal species. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2014 (3) that, under the proposed conditions of use in feed this substance does not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of tannic acid in feed is similar to that on food. The Authority has already concluded that for food tannic acid is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that in the absence of data on user safety tannic acid should be considered as potentially hazardous to the respiratory tract, skin, eyes and mucous membranes. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

The assessment of the substance concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of tannic acid should be authorised as specified in the Annex to this Regulation.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for tannic acid, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.   The substance 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 substance 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 substance 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 3

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)   OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)   EFSA Journal 2014;12(10):3828.

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

2b16080

—

Tannic acid

Additive composition

Tannic acid

Characterisation of the active substance

Tannic acid

Produced by extraction from different plants.

Purity: min. 93 % on dry matter basis

Chemical formula: C76H52O46

CAS number 72401-53-7

FLAVIS No: 16.080

Method of analysis  (1)

For the determination of tannic acid, in the feed additive:

Qualitative colorimetric or precipitation tests (Ph. Eur. 6th edition, monograph 1477) and quantitative gravimetric method (FAO JECFA tannic acid monograph).

For the identification of tannic acid (as gallic acid) in the premixture of flavourings:

Reversed Phase High Performance Liquid Chromatography coupled to UV detector(RP-HPLC-UV).

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: 15 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 %:15 mg/kg’.

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: 15 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 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 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