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Document 32023R0565

Commission Implementing Regulation (EU) 2023/565 of 10 March 2023 concerning the authorisation of ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene as feed additives for all animal species (Text with EEA relevance)

C/2023/1555

OJ L 74, 13.3.2023, p. 10–46 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg_impl/2023/565/oj

13.3.2023   

EN

Official Journal of the European Union

L 74/10

COMMISSION IMPLEMENTING REGULATION (EU) 2023/565

of 10 March 2023

concerning the authorisation of ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene 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(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

The substances ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products belonging to the functional group of flavouring compounds, in accordance with Article 10(1), point (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 authorisation of the above-mentioned substances as feed additives for all animal species. The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(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 applicant withdrew the application for water for drinking for all the substances concerned.

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 March 2012 (3), 25 April 2012 (4), 17 October 2012 (5) (6), 13 November 2012 (7), 12 March 2013 (8), 10 March 2015 (9), 8 March 2016 (10), 20 April 2016 (11), 12 July 2016 (12), 28 February 2019 (13), 18 November 2020 (14) and 23 March 2022 (15) that, under the proposed conditions of use, the substances do not have adverse effects on animal health, consumer safety or the environment. The Authority concluded that for 2-methyl-1-phenylpropan-2-ol, beta-damascone, alpha-irone, (E)-beta-damascone, phenethyl isovalerate, 4-(p-hydroxyphenyl) butan-2-one, and 2-isopropyl-4-methylthiazole, the safe use level for the marine environment is estimated to be 0,05 mg/kg feed.

(6)

The Authority also concluded that all the substances should be considered as irritants to skin and eyes and as potential skin and respiratory sensitisers in susceptible individuals. In the absence of data for hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate and allyl heptanoate, the Authority could not conclude that users can safely handle those substances. However, the applicant, as required, produced a safety data sheet where hazards for users have been identified for those substances. The hazards described in the safety data sheet were, in particular, hazards for skin, eye contact and respiratory exposure for hex-2(trans)-enal, hazards for skin and eye contact for hex-2-en-1-ol and allyl heptanoate and harmful if swallowed and toxic in contact with skin for allyl hexanoate.

(7)

The Authority finally concluded that all substances are recognised to flavour food and their 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 all the substances 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. 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.

(9)

Certain conditions should be provided for to allow better control. In particular, a recommended maximum 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 substances are not authorised for use as 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 provide for a transitional period for the 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 2 October 2023 in accordance with the rules applicable before 2 April 2023 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 2 April 2024 in accordance with the rules applicable before 2 April 2023 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 2 April 2025 in accordance with the rules applicable before 2 April 2023 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, 10 March 2023.

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(3):2625.

(4)  EFSA Journal 2012;10(5):2678.

(5)  EFSA Journal 2012;10(10):2927.

(6)  EFSA Journal 2012;10(10):2928.

(7)  EFSA Journal 2012;10(11):2966.

(8)  EFSA Journal 2013;11(4):3169.

(9)  EFSA Journal 2015;13(3):4053.

(10)  EFSA Journal 2016;14(6):4441.

(11)  EFSA Journal 2016;14(6):4475.

(12)  EFSA Journal 2016;14(8):4557.

(13)  EFSA Journal 2019;17(3):5654.

(14)  EFSA Journal 2020;18(12):6338.

(15)  EFSA Journal 2022;20(4):7248.

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

2b09093

Ethyl heptanoate

Additive composition

Ethyl heptanoate

Characterisation of active substance

Ethyl heptanoate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C9H18O2

CAS number: 106-30-9

FLAVIS: 09.093

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%: 32 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (1)

For the determination of ethyl heptanoate 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

2b09409

Ethyl 2-methylbutyrate

Additive composition

Ethyl 2-methylbutyrate

Characterisation of active substance

Ethyl 2-methylbutyrate

Produced by chemical synthesis

Purity: min. 95%

Chemical formula: C7H14O2

CAS number: 7452-79-1

FLAVIS: 09.409

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%: 25 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (2)

For the determination of ethyl 2-methylbutyrate 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

2b09024

Isopentyl acetate

Additive composition

Isopentyl acetate

Characterisation of active substance

Isopentyl acetate

Produced by chemical synthesis

Purity: min. 95%

Chemical formula: C7H14O2

CAS number: 123-92-2

FLAVIS: 09.024

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%: 125 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (3)

For the determination of isopentyl 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

2b09463

3-Methylbutyl 3-methylbutyrate

Additive composition

3-Methylbutyl 3-methylbutyrate

Characterisation of active substance

3-Methylbutyl 3-methylbutyrate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C10H20O2

CAS number: 659-70-1

FLAVIS: 09.463

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%: 25 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (4)

For the determination of 3-methylbutyl 3-methylbutyrate 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

2b08006

2-Methylpropionic acid

Additive composition

2-Methylpropionic acid

Characterisation of active substance

2-Methylpropionic acid

Produced by chemical synthesis

Purity: min. 99%

Chemical formula: C4H8O2

CAS number: 79-31-2

FLAVIS: 08.006

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%: 25 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (5)

For the determination of 2-methylpropionic 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

2b09055

3-Methylbutyl butyrate

Additive composition

3-Methylbutyl butyrate

Characterisation of active substance

3-Methylbutyl butyrate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C9H18O2

CAS number: 106-27-4

FLAVIS: 09.055

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%: 25 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (6)

For the determination of 3-methylbutyl 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

2b09286

2-Methylbutyl acetate

Additive composition

2-Methylbutyl acetate

Characterisation of active substance

2-Methylbutyl acetate

Produced by chemical synthesis

Purity: min. 99%

Chemical formula: C7H14O2

CAS number: 624-41-9

FLAVIS: 09.286

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%: 25 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (7)

For the determination of 2-methylbutyl 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

2b02020

Hex-2-en-1-ol

Additive composition

Hex-2-en-1-ol

Characterisation of active substance

Hex-2-en-1-ol

Produced by chemical synthesis

Purity: min. 95%

Chemical formula: C6H12O

CAS number: 2305-21-7

FLAVIS: 02.020

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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (8)

For the determination of hex-2-en-1-ol 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

2b05073

Hex-2(trans)-enal

Additive composition

Hex-2(trans)-enal

Characterisation of active substance

Hex-2(trans)-enal

Produced by chemical synthesis

Purity: min. 92%

Chemical formula: C6H10O

CAS number: 6728-26-3

FLAVIS: 05.073

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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (9)

For the determination of hex-2(trans)-enal 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

2b09244

Allyl hexanoate

Additive composition

Allyl hexanoate

Characterisation of active substance

Allyl hexanoate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C9H16O2

CAS number: 123-68-2

FLAVIS: 09.244

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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (10)

For the determination of allyl hexanoate 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

2b09097

Allyl heptanoate

Additive composition

Allyl heptanoate

Characterisation of active substance

Allyl heptanoate

Produced by chemical synthesis

Purity: min. 97%

Chemical formula: C10H18O2

CAS number: 142-19-8

FLAVIS: 09.097

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.

5.

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

2 April 2033

Analytical method  (11)

For the determination of allyl heptanoate 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

2b02013

Linalool

Additive composition

Linalool

Characterisation of active substance

Linalool

Produced by chemical synthesis or by fractional distillation and subsequent rectification from the oils of Cajenne rosewood, Brazil rosewood, Mexican linaloe, shiu and coriander seeds.

Purity: min. 95%

Chemical formula: C10H18O

CAS number: 78-70-6

FLAVIS: 02.013

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%: 30 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (12)

For the determination of linalool 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

2b02035

2-Methyl-1-phenylpropan-2-ol

Additive composition

2-Methyl-1-phenylpropan-2-ol

Characterisation of active substance

2-Methyl-1-phenylpropan-2-ol

Produced by chemical synthesis

Purity: min. 97%

Chemical formula: C10H14O

CAS number: 100-86-7

FLAVIS: 02.035

All animals 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%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

—

animals farmed in land-based aquaculture systems: 5 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.

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’.

—

‘Intended for animals farmed in land-based aquaculture systems’

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (13)

For the determination of 2-methyl-1-phenylpropan-2-ol 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

2b07007

alpha-Ionone

Additive composition

alpha-Ionone

Characterisation of active substance

alpha-Ionone

Produced by chemical synthesis

Purity: min. > 85%

Chemical formula: C13H20O

CAS number: 127-41-3

FLAVIS: 07.007

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%: 25 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (14)

For the determination of alpha-ionone 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

2b07083

beta-Damascone

Additive composition

beta-Damascone

Characterisation of active substance

beta-Damascone

Produced by chemical synthesis

Purity: min. > 90%

Chemical formula: C13H20O

CAS number: 23726-92-3

FLAVIS: 07.083

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%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

—

animals farmed in land-based aquaculture systems: 5 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.

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

—

‘Intended for animals farmed in land-based aquaculture systems’

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (15)

For the determination of beta-damascone 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

2b07089

Nootkatone

Additive composition

Nootkatone

Characterisation of active substance

Nootkatone

Produced by chemical synthesis

Purity: min. > 93%

Chemical formula: C15H22O

CAS number: 4674-50-4

FLAVIS: 07.089

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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (16)

For the determination of nootkatone 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

2b07008

beta-Ionone

Additive composition

beta-Ionone

Characterisation of active substance

beta-Ionone

Produced by chemical synthesis

Purity: min. > 95%

Chemical formula: C13H20O

CAS number: 14901-07-6

FLAVIS: 07.008

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%:

—

salmonids, veal calves and dogs: 5 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (17)

For the determination of beta-ionone 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

2b07011

alpha-Irone

Additive composition

alpha-Irone

Characterisation of active substance

alpha-Irone

Produced by chemical synthesis

Purity: min. > 98%

Chemical formula: C14H22O

CAS number: 79-69-6

FLAVIS: 07.011

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%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

—

animals farmed in land-based aquaculture systems: 5 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.

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

—

‘Intended for animals farmed in land-based aquaculture systems’

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (18)

For the determination of alpha-irone 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

2b07108

beta-Damascenone

Additive composition

beta-Damascenone

Characterisation of active substance

beta-Damascenone

Produced by chemical synthesis

Purity: min. > 98%

Chemical formula: C13H18O

CAS number: 23696-85-7

FLAVIS: 07.108

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%:

—

cattle for fattening, salmonids and non-food producing animals: 1.5 mg;

—

other species and categories: 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (19)

For the determination of beta-damascenone 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

2b07224

(E)-beta-Damascone

Additive composition

(E)-beta-Damascone

Characterisation of active substance

(E)-beta-Damascone

Produced by chemical synthesis

Purity: min. > 90%

Chemical formula: C13H20O

CAS number: 23726-91-2

FLAVIS: 07.224

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%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

—

animals farmed in land-based aquaculture systems: 5 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.

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

—

‘Intended for animals farmed in land-based aquaculture systems’

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (20)

For the determination of (E)-beta-damascone 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

2b10004

Pentadecano-1,15-lactone

Additive composition

Pentadecano-1,15-lactone

Characterisation of active substance

Pentadecano-1,15-lactone

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C15H28O2

CAS number: 106-02-5

FLAVIS: 10.004

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%: 10 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (21)

For the determination of pentadecano-1,15-lactone 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

2b02019

2-Phenylethan-1-ol

Additive composition

2-Phenylethan-1-ol

Characterisation of active substance

2-Phenylethan-1-ol

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C8H10O

CAS number: 60-12-8

FLAVIS: 02.019

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%: 25 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (22)

For the determination of 2-phenylethan-1-ol 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

2b09466

Phenethyl isovalerate

Additive composition

Phenethyl isovalerate

Characterisation of active substance

Phenethyl isovalerate

Produced by chemical synthesis

Purity: min. > 97%

Chemical formula: C13H18O2

CAS number: 140-26-1

FLAVIS: 09.466

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%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

—

animals farmed in land-based aquaculture systems: 30 mg;

—

other species or categories of animals: 30 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.

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

—

‘Intended for animals farmed in land-based aquaculture systems’

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (23)

For the determination of phenethyl 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

2b07055

4-(p-Hydroxyphenyl)butan-2-one

Additive composition

4-(p-Hydroxyphenyl)butan-2-one

Characterisation of active substance

4-(p-Hydroxyphenyl)butan-2-one

Produced by chemical synthesis

Purity: min. > 96%

Chemical formula: C10H12O2

CAS number: 5471-51-2

FLAVIS: 07.055

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%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

—

animals farmed in land-based aquaculture systems: 25 mg

—

other species or categories of animals: 25 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.

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

—

‘Intended for animals farmed in land-based aquaculture systems’

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (24)

For the determination of 4-(p-hydroxyphenyl)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

2b04074

2-Methoxynaphthalene

Additive composition

2-Methoxynaphthalene

Characterisation of active substance

2-Methoxynaphthalene

Produced by chemical synthesis

Purity: min. 99%

Chemical formula: C11H10O

CAS number: 93-04-9

FLAVIS: 04.074

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%: 1.2 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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (25)

For the determination of 2-methoxynaphthalene 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

2b15026

2-Isopropyl-4-methylthiazole

Additive composition

2-Isopropyl-4-methylthiazole

Characterisation of active substance

2-Isopropyl-4-methylthiazole

Produced by chemical synthesis

Purity: min. 96%

Chemical formula: C7H11NS

CAS number: 15679-13-7

FLAVIS: 15.026

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%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

—

animals farmed in land-based aquaculture systems:1.5mg

—

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.

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

—

‘Intended for animals farmed in land-based aquaculture systems’

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (26)

For the determination of 2-isopropyl-4-methylthiazole 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

2b01017

Valencene

Additive composition

Valencene

Characterisation of active substance

Valencene

Produced by chemical synthesis

Purity: min. 94%

Chemical formula: C15H24

CAS number: 4630-07-3

FLAVIS: 01.017

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.

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 skin, eye and breathing protection.

2 April 2033

Analytical method  (27)

For the determination of valencene 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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(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

(20)  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

(21)  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

(22)  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

(23)  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

(24)  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

(25)  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

(26)  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

(27)  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

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