COMMISSION IMPLEMENTING REGULATION (EU) 2022/1250

of 19 July 2022

concerning the authorisation of ethyl acrylate, pentyl isovalerate, butyl 2-methyl butyrate, 2-methylundecanal, (

2E

)-methylcrotonic acid, ethyl (

E,Z

)-deca-2,4-dienoate, butan-2-one, cyclohexyl acetate, 3,4-dimethylcyclopentan-1,2-dione, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one, phenethyl butyrate, hexyl phenylacetate, 4-methylacetophenone, 4-methoxyacetophenone, 3-methylphenol, 3,4-dimethylphenol, 1-methoxy-4-methylbenzene, trimethyloxazole and 4,5-dihydrothiophen-3(2H)-one 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 an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2) The substances ethyl acrylate, pentyl isovalerate, butyl 2-methyl butyrate, 2-methylundecanal, (

)-methylcrotonic acid, ethyl (

E,Z

)-deca-2,4-dienoate, butan-2-one, cyclohexyl acetate, 3,4-dimethylcyclopentan-1,2-dione, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one, phenethyl butyrate, hexyl phenylacetate, 4-methylacetophenone, 4-methoxyacetophenone, 3-methylphenol, 3,4-dimethylphenol, 1-methoxy-4-methylbenzene, trimethyloxazole and 4,5-dihydrothiophen-3(2H)-one were authorised without a time limit in accordance with Directive 70/524/EEC as a feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) 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, several applications were submitted for the re-evaluation of those additives for all animal species.

(4) The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore, the use of these additives in water for drinking should not be allowed.

(5) The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(6) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 1 February 2012 (3), 7 March 2012 (4), 25 April 2012 (5), 17 October 2012 (6), 12 March 2013 (7), 5 March 2014 (8), 20 October 2015 (9), 26 January 2016 (10), 8 March 2016 (11), 20 April 2016 (12), 25 May 2016 (13), 12 July 2016 (14) and 19 October 2016 (15), that, under the proposed conditions of use, the additives do not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that the additives should be considered as irritants to skin, eyes and respiratory tract and as skin sensitizers. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(7) The Authority concluded, that the additives are recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(8) The assessment of the additives 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.

(9) Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.

(10) The fact that the additives are not authorised for use as a flavourings in water for drinking does not preclude their use in compound feed which is administered via water.

(11) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of 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.

(12) 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 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 these substances, which are produced and labelled before 9 February 2023 in accordance with the rules applicable before 9 August 2022 may continue to be placed on the market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing these substances as specified in the Annex which are produced and labelled before 9 August 2023 in accordance with the rules applicable before 9 August 2022 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 these substances as specified in the Annex which are produced and labelled before 9 August 2024 in accordance with the rules applicable before 9 August 2022 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, 19 July 2022.

For the Commission

The President

Ursula VON DER LEYEN

(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(2):2573.

(4)

EFSA Journal

2012;10(3):2625.

(5)

EFSA Journal

2012;10(5):2678.

(6)

EFSA Journal

2012;10(10):2927.

(7)

EFSA Journal

2013;11(4):3169.

(8)

EFSA Journal

2014;12(3):3608.

(9)

EFSA Journal

2015;13(11):4268.

(10)

EFSA Journal

2016;14(2):4390.

(11)

EFSA Journal

2016;14(6):4441.

(12)

EFSA Journal

2016;14(6):4475.

(13)

EFSA Journal

2016;14(6):4512.

(14)

EFSA Journal

2016;14(8):4557.

(15)

EFSA Journal

2016;14(11):4618.

ANNEX

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b09037

Ethyl acrylate

Additive composition

Ethyl acrylate

Characterisation of active substance

Ethyl acrylate

Produced by chemical synthesis

Purity: 97 %

Chemical formula: C5H8O2

CAS number: 140-88-5

FLAVIS: 09.037

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	pigs and poultry: 1 mg;

—	other species or categories of animals: 1,5 mg.’

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

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 skin, eye and breathing protection.

9 August 2032

Analytical method (1)

For the identification of ethyl acrylate in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b09499

Pentyl isovalerate

Additive composition

Pentyl isovalerate

Characterisation of active substance

Pentyl isovalerate

Produced by chemical synthesis

Purity: 98 %

Chemical formula: C10H20O2

CAS number: 25415-62-7

FLAVIS: 09.499

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	pigs and poultry: 1 mg;

—	other species or categories of animals: 1,5 mg.’

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

9 August 2032

Analytical method (2)

For the identification of pentyl isovalerate in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b09519

Butyl 2-methyl butyrate

Additive composition

Butyl 2-methyl butyrate

Characterisation of active substance

Butyl 2-methyl butyrate

Produced by chemical synthesis

Purity: 95 %

Chemical formula: C9H18O2

CAS number: 15706-73-7

FLAVIS: 09.519

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	pigs and poultry: 1 mg;

—	other species or categories of animals: 1,5 mg.’

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

9 August 2032

Analytical method (3)

For the identification of butyl 2-methyl butyrate in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b05077

2-Methylundecanal

Additive composition

2-Methylundecanal

Characterisation of active substance

2-Methylundecanal

Produced by chemical synthesis

Purity: 97 %

Chemical formula: C12H24O

CAS number: 110-41-8

FLAVIS: 05.077

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	pigs and poultry: 1 mg;

—	other species or categories of animals: 1,5 mg.’

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

9 August 2032

Analytical method (4)

For the identification of 2-methylundecanal in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b08064

(2E)-Methylcrotonic acid

Additive composition

(2E)-Methylcrotonic acid

Characterisation of active substance

(2E)-Methylcrotonic acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C5H8O2

CAS number: 80-59-1

FLAVIS: 08.064

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	marine animals: 0,05 mg;

—	other species or categories of animals: 1 mg.’

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

9 August 2032

Analytical method (5)

For the identification of (2E)-methylcrotonic acid in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b09260

Ethyl (E,Z)-deca-2,4-dienoate

Additive composition

Ethyl (E,Z)-deca-2,4-dienoate

Characterisation of active substance

Ethyl (E,Z)-deca-2,4-dienoate

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C12H20O2

CAS number: 3025-30-7

FLAVIS: 09.260

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	marine animals: 0,05 mg;

—	other species or categories of animals: 1 mg.’

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

9 August 2032

Analytical method (6)

For the identification of ethyl (EZ)-deca-2,4-dienoate in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b07053

Butan-2-one

Additive composition

Butan-2-one

Characterisation of active substance

Butan-2-one

Produced by chemical synthesis

Purity: min. 99,5 %

Chemical formula: C4H8O

CAS number: 78-93-3

FLAVIS: 07.053

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	pigs and poultry: 1 mg;

—	other species or categories of animals: 1,5 mg.’

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

9 August 2032

Analytical method (7)

For the identification of butan-2-one in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b09027

Cyclohexyl acetate

Additive composition

Cyclohexyl acetate

Characterisation of active substance

Cyclohexyl acetate

Produced by chemical synthesis

Purity: > 98 %

Chemical formula: C8H14O2

CAS number: 622-45-7

FLAVIS: 09.027

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	marine animals: 0,05 mg;

—	other species or categories of animals: 1 mg.’

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

9 August 2032

Analytical method (8)

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

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b07075

3,4-Dimethylcyclopentan-1,2-dione

Additive composition

3,4-Dimethylcyclopentan-1,2-dione

Characterisation of active substance

3,4-Dimethylcyclopentan-1,2-dione

Produced by chemical synthesis

Purity: > 98 %

Chemical formula: C7H10O2

CAS number: 13494-06-9

FLAVIS: 07.075

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	cats and dogs: 5 mg;

—	marine animals: 0,05 mg

—	other species or categories of animals: 0,5 mg.’

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

9 August 2032

Analytical method (9)

For the identification of 3,4-dimethylcyclopentan-1,2-dione in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b10023

5-Ethyl-3-hydroxy-4-methylfuran-2(5H)-one

Additive composition

5-Ethyl-3-hydroxy-4-methylfuran-2(5H)-one

Characterisation of active substance

5-Ethyl-3-hydroxy-4-methylfuran-2(5H)-one

Produced by chemical synthesis

Purity: 95 %

Chemical formula: C7H10O3

CAS number: 698–10–2

FLAVIS: 10.023

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	marine animals: 0,05 mg;

—	poultry and pigs: 0,05 mg;

—	other species or categories of animals: 0,08 mg.’

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

9 August 2032

Analytical method (10)

For the identification of 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b09168

Phenethyl butyrate

Additive composition

Phenethyl butyrate

Characterisation of active substance

Phenethyl butyrate

Produced by chemical synthesis

Purity: 97 %

Chemical formula: C12H16O2

CAS number: 103-52-6

FLAVIS: 09.168

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	pigs and poultry: 1 mg;

—	other species or categories of animals: 1,5 mg.’

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

9 August 2032

Analytical method (11)

For the identification of phenethyl butyrate in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b09804

Hexyl phenylacetate

Additive composition

Hexyl phenylacetate

Characterisation of active substance

Hexyl phenylacetate

Produced by chemical synthesis

Purity: 97 %

Chemical formula: C14H20O2

CAS number: 5421-17-0

FLAVIS: 09.804

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	pigs and poultry: 1 mg;

—	other species or categories of animals: 1,5 mg.’

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

9 August 2032

Analytical method (12)

For the identification of hexyl phenylacetate in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b07022

4-Methylacetophenone

Additive composition

4-Methylacetophenone

Characterisation of active substance

4-Methylacetophenone

Produced by chemical synthesis

Purity: > 95 %

Chemical formula: C9H10O

CAS number: 122-00-9

FLAVIS: 07.022

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	marine animals: 0,05 mg;

—	cats: 1 mg;

—	other species or categories of animals: 5 mg.’

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

9 August 2032

Analytical method (13)

For the identification of 4-methylacetophenone in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b07038

4-Methoxyacetophenone

Additive composition

4-Methoxyacetophenone

Characterisation of active substance

4-Methoxyacetophenone

Produced by chemical synthesis

Purity: > 97 %

Chemical formula: C9H10O2

CAS number: 100-06-1

FLAVIS: 07.038

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	marine animals: 0,05 mg;

—	cats: 1 mg;

—	other species or categories of animals: 5 mg.’

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

9 August 2032

Analytical method (14)

For the identification of 4-methoxyacetophenone in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b04026

3-Methylphenol

Additive composition

3-Methylphenol

Characterisation of active substance

3-Methylphenol

Produced by chemical synthesis

Purity: 98 %

Chemical formula: C7H8O

CAS number: 108-39-4

FLAVIS: 04.026

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 conditions and stability to heat treatment shall be indicated.

3.	On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 5 mg.’

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

9 August 2032

Analytical method (15)

For the identification of 3-methylphenol in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b04048

3,4-Dimethylphenol

Additive composition

3,4-Dimethylphenol

Characterisation of active substance

3,4-Dimethylphenol

Produced by chemical synthesis

Purity: 98 %

Chemical formula: C8H10O

CAS number: 95-65-8

FLAVIS: 04.048

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 conditions and stability to heat treatment shall be indicated.

3.	On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 5 mg.’

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

9 August 2032

Analytical method (16)

For the identification of 3,4-dimethylphenol in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b04015

1-Methoxy-4-methylbenzene

Additive composition

1-Methoxy-4-methylbenzene

Characterisation of active substance

1-Methoxy-4-methylbenzene

Produced by chemical synthesis

Purity: 99 %

Chemical formula: C8H10O

CAS number: 104-93-8

FLAVIS: 04.015

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 conditions and stability to heat treatment shall be indicated.

3.	On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 1 mg.’

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

9 August 2032

Analytical method (17)

For the identification of 1-methoxy-4-methylbenzene in the feed additive and in feed flavouring premixtures:

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b13169

Trimethyloxazole

Additive composition

Trimethyloxazole

Characterisation of active substance

Trimethyloxazole

Produced by chemical synthesis

Purity: > 95 %

Chemical formula: C6H9ON

CAS number: 20662-84-4

FLAVIS: 13.169

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 conditions and stability to heat treatment shall be indicated.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—	marine animals: 0,05 mg;

—	poultry and pigs: 0,3 mg;

—	other species or categories of animals: 0,5 mg.’

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

9 August 2032

Analytical method (18)

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

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

Identification number of the additive

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b15012

4,5-Dihydrothiophen-3(2H)-one

Additive composition

4,5-Dihydrothiophen-3(2H)-one

Characterisation of active substance

4,5-Dihydrothiophen-3(2H)-one

Produced by chemical synthesis.

Purity: 97 %

Chemical formula: C4H6OS

CAS number: 1003-04-9

FLAVIS: 15.012

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 conditions and stability to heat treatment shall be indicated.

3.	On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 0,05 mg.’

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

9 August 2032

Analytical method (19)

For the identification of 4,5-dihydrothiophen-3(2H)-one in the feed additive and in feed flavouring premixtures:

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

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(3) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(4) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(5) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(6) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(7) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(8) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(9) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(10) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(11) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(12) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(13) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(14) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(15) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(16) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(17) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(18) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(19) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en