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)
Date: 2023-03-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, flavouring, market approval




L_2023074EN.01001001.xml










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