Commission Implementing Regulation (EU) 2022/1250 of 19 July 2022 concerning the authorisation of ethyl acrylate, pentyl isovalerate, butyl 2-methyl butyrate, 2-methylundecanal, (2E)-methylcrotonic acid, ethyl (E,Z)-deca-2,4-dienoate, butan-2-one, cyclohexyl acetate, 3,4-dimethylcyclopentan-1,2-dione, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one, phenethyl butyrate, hexyl phenylacetate, 4-methylacetophenone, 4-methoxyacetophenone, 3-methylphenol, 3,4-dimethylphenol, 1-methoxy-4-methylbenzene, trimethyloxazole and 4,5-dihydrothiophen-3(2H)-one as feed additives for all animal species (Text with EEA relevance)
Date: 2022-07-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, flavouring, market approval




L_2022191EN.01001301.xml










20.7.2022   


EN


Official Journal of the European Union


L 191/13








            COMMISSION IMPLEMENTING REGULATION (EU) 2022/1250
of 19 July 2022
         
concerning the authorisation of ethyl acrylate, pentyl isovalerate, butyl 2-methyl butyrate, 2-methylundecanal, (2E)-methylcrotonic acid, ethyl (E,Z)-deca-2,4-dienoate, butan-2-one, cyclohexyl acetate, 3,4-dimethylcyclopentan-1,2-dione, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one, phenethyl butyrate, hexyl phenylacetate, 4-methylacetophenone, 4-methoxyacetophenone, 3-methylphenol, 3,4-dimethylphenol, 1-methoxy-4-methylbenzene, trimethyloxazole and 4,5-dihydrothiophen-3(2H)-one as feed additives for all animal species
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


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

Whereas:







(1)


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












(2)


The substances ethyl acrylate, pentyl isovalerate, butyl 2-methyl butyrate, 2-methylundecanal, (2E)-methylcrotonic acid, ethyl (E,Z)-deca-2,4-dienoate, butan-2-one, cyclohexyl acetate, 3,4-dimethylcyclopentan-1,2-dione, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one, phenethyl butyrate, hexyl phenylacetate, 4-methylacetophenone, 4-methoxyacetophenone, 3-methylphenol, 3,4-dimethylphenol, 1-methoxy-4-methylbenzene, trimethyloxazole and 4,5-dihydrothiophen-3(2H)-one were authorised without a time limit in accordance with Directive 70/524/EEC as a feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.












(3)


In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, several applications were submitted for the re-evaluation of those additives for all animal species.












(4)


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












(5)


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












(6)


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












(7)


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












(8)


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












(9)


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












(10)


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












(11)


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












(12)


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





HAS ADOPTED THIS REGULATION:



Article 1

Authorisation

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


Article 2

Transitional measures


1.   The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 9 February 2023 in accordance with the rules applicable before 9 August 2022 may continue to be placed on the market and used until the existing stocks are exhausted.


2.   Compound feed and feed materials containing these substances as specified in the Annex which are produced and labelled before 9 August 2023 in accordance with the rules applicable before 9 August 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.


3.   Compound feed and feed materials containing these substances as specified in the Annex which are produced and labelled before 9 August 2024 in accordance with the rules applicable before 9 August 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.



Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 July 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

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

(3)  
            EFSA Journal 2012;10(2):2573.

(4)  
            EFSA Journal 2012;10(3):2625.

(5)  
            EFSA Journal 2012;10(5):2678.

(6)  
            EFSA Journal 2012;10(10):2927.

(7)  
            EFSA Journal 2013;11(4):3169.

(8)  
            EFSA Journal 2014;12(3):3608.

(9)  
            EFSA Journal 2015;13(11):4268.

(10)  
            EFSA Journal 2016;14(2):4390.

(11)  
            EFSA Journal 2016;14(6):4441.

(12)  
            EFSA Journal 2016;14(6):4475.

(13)  
            EFSA Journal 2016;14(6):4512.

(14)  
            EFSA Journal 2016;14(8):4557.

(15)  
            EFSA Journal 2016;14(11):4618.




ANNEX













Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b09037


Ethyl acrylate



Additive composition

Ethyl acrylate

Characterisation of active substance

Ethyl acrylate
Produced by chemical synthesis
Purity: 97 %
Chemical formula: C5H8O2

CAS number: 140-88-5
FLAVIS: 09.037


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


pigs and poultry: 1 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (1)

For the identification of ethyl acrylate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b09499


Pentyl isovalerate



Additive composition

Pentyl isovalerate

Characterisation of active substance

Pentyl isovalerate
Produced by chemical synthesis
Purity: 98 %
Chemical formula: C10H20O2

CAS number: 25415-62-7
FLAVIS: 09.499


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


pigs and poultry: 1 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (2)

For the identification of pentyl isovalerate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b09519


Butyl 2-methyl butyrate



Additive composition

Butyl 2-methyl butyrate

Characterisation of active substance

Butyl 2-methyl butyrate
Produced by chemical synthesis
Purity: 95 %
Chemical formula: C9H18O2

CAS number: 15706-73-7
FLAVIS: 09.519


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


pigs and poultry: 1 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (3)

For the identification of butyl 2-methyl butyrate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b05077


2-Methylundecanal



Additive composition

2-Methylundecanal

Characterisation of active substance

2-Methylundecanal
Produced by chemical synthesis
Purity: 97 %
Chemical formula: C12H24O
CAS number: 110-41-8
FLAVIS: 05.077


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


pigs and poultry: 1 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (4)

For the identification of 2-methylundecanal in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


 


-


-


-




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b08064


(2E)-Methylcrotonic acid



Additive composition

(2E)-Methylcrotonic acid

Characterisation of active substance

(2E)-Methylcrotonic acid
Produced by chemical synthesis
Purity: min. 99 %
Chemical formula: C5H8O2

CAS number: 80-59-1
FLAVIS: 08.064


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


marine animals: 0,05 mg;










—


other species or categories of animals: 1 mg.’














4.


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










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.






9 August 2032





Analytical method
 (5)

For the identification of (2E)-methylcrotonic acid in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b09260


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



Additive composition

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

Characterisation of active substance

Ethyl (E,Z)-deca-2,4-dienoate
Produced by chemical synthesis
Purity: min. 90 %
Chemical formula: C12H20O2

CAS number: 3025-30-7
FLAVIS: 09.260


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


marine animals: 0,05 mg;










—


other species or categories of animals: 1 mg.’














4.


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










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.






9 August 2032





Analytical method
 (6)

For the identification of ethyl (EZ)-deca-2,4-dienoate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b07053


Butan-2-one



Additive composition

Butan-2-one

Characterisation of active substance

Butan-2-one
Produced by chemical synthesis
Purity: min. 99,5 %
Chemical formula: C4H8O
CAS number: 78-93-3
FLAVIS: 07.053


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


pigs and poultry: 1 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (7)

For the identification of butan-2-one in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b09027


Cyclohexyl acetate



Additive composition

Cyclohexyl acetate

Characterisation of active substance

Cyclohexyl acetate
Produced by chemical synthesis
Purity: > 98 %
Chemical formula: C8H14O2

CAS number: 622-45-7
FLAVIS: 09.027


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


marine animals: 0,05 mg;










—


other species or categories of animals: 1 mg.’














4.


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










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.






9 August 2032





Analytical method
 (8)

For the identification of cyclohexyl acetate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b07075


3,4-Dimethylcyclopentan-1,2-dione



Additive composition

3,4-Dimethylcyclopentan-1,2-dione

Characterisation of active substance

3,4-Dimethylcyclopentan-1,2-dione
Produced by chemical synthesis
Purity: > 98 %
Chemical formula: C7H10O2

CAS number: 13494-06-9
FLAVIS: 07.075


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


cats and dogs: 5 mg;










—


marine animals: 0,05 mg










—


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














4.


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










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.






9 August 2032





Analytical method
 (9)

For the identification of 3,4-dimethylcyclopentan-1,2-dione in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b10023


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



Additive composition

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

Characterisation of active substance

5-Ethyl-3-hydroxy-4-methylfuran-2(5H)-one
Produced by chemical synthesis
Purity: 95 %
Chemical formula: C7H10O3

CAS number: 698–10–2
FLAVIS: 10.023


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


marine animals: 0,05 mg;










—


poultry and pigs: 0,05 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (10)

For the identification of 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b09168


Phenethyl butyrate



Additive composition

Phenethyl butyrate

Characterisation of active substance

Phenethyl butyrate
Produced by chemical synthesis
Purity: 97 %
Chemical formula: C12H16O2

CAS number: 103-52-6
FLAVIS: 09.168


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


pigs and poultry: 1 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (11)

For the identification of phenethyl butyrate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


 


-


-


-




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b09804


Hexyl phenylacetate



Additive composition

Hexyl phenylacetate

Characterisation of active substance

Hexyl phenylacetate
Produced by chemical synthesis
Purity: 97 %
Chemical formula: C14H20O2

CAS number: 5421-17-0
FLAVIS: 09.804


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


pigs and poultry: 1 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (12)

For the identification of hexyl phenylacetate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


 


-


-


-




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b07022


4-Methylacetophenone



Additive composition

4-Methylacetophenone

Characterisation of active substance

4-Methylacetophenone
Produced by chemical synthesis
Purity: > 95 %
Chemical formula: C9H10O
CAS number: 122-00-9
FLAVIS: 07.022


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


marine animals: 0,05 mg;










—


cats: 1 mg;










—


other species or categories of animals: 5 mg.’














4.


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










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.






9 August 2032





Analytical method
 (13)

For the identification of 4-methylacetophenone in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b07038


4-Methoxyacetophenone



Additive composition

4-Methoxyacetophenone

Characterisation of active substance

4-Methoxyacetophenone
Produced by chemical synthesis
Purity: > 97 %
Chemical formula: C9H10O2

CAS number: 100-06-1
FLAVIS: 07.038


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


marine animals: 0,05 mg;










—


cats: 1 mg;










—


other species or categories of animals: 5 mg.’














4.


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










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.






9 August 2032





Analytical method
 (14)

For the identification of 4-methoxyacetophenone in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b04026


3-Methylphenol



Additive composition

3-Methylphenol

Characterisation of active substance

3-Methylphenol
Produced by chemical synthesis
Purity: 98 %
Chemical formula: C7H8O
CAS number: 108-39-4
FLAVIS: 04.026


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










3.


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










4.


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










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.






9 August 2032





Analytical method
 (15)

For the identification of 3-methylphenol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b04048


3,4-Dimethylphenol



Additive composition

3,4-Dimethylphenol

Characterisation of active substance

3,4-Dimethylphenol
Produced by chemical synthesis
Purity: 98 %
Chemical formula: C8H10O
CAS number: 95-65-8
FLAVIS: 04.048


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










3.


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










4.


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










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.






9 August 2032





Analytical method
 (16)

For the identification of 3,4-dimethylphenol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b04015


1-Methoxy-4-methylbenzene



Additive composition

1-Methoxy-4-methylbenzene

Characterisation of active substance

1-Methoxy-4-methylbenzene
Produced by chemical synthesis
Purity: 99 %
Chemical formula: C8H10O
CAS number: 104-93-8
FLAVIS: 04.015


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










3.


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










4.


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










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.






9 August 2032





Analytical method
 (17)

For the identification of 1-methoxy-4-methylbenzene in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b13169


Trimethyloxazole



Additive composition

Trimethyloxazole

Characterisation of active substance

Trimethyloxazole
Produced by chemical synthesis
Purity: > 95 %
Chemical formula: C6H9ON
CAS number: 20662-84-4
FLAVIS: 13.169


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










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 %:






—


marine animals: 0,05 mg;










—


poultry and pigs: 0,3 mg;










—


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














4.


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










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.






9 August 2032





Analytical method
 (18)

For the identification of trimethyloxazole in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.




















Identification number of the additive


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




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





Category: Sensory additives


Functional group: Flavouring compounds





2b15012


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



Additive composition

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

Characterisation of active substance

4,5-Dihydrothiophen-3(2H)-one
Produced by chemical synthesis.
Purity: 97 %
Chemical formula: C4H6OS
CAS number: 1003-04-9
FLAVIS: 15.012


All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










3.


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










4.


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










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.






9 August 2032





Analytical method
 (19)

For the identification of 4,5-dihydrothiophen-3(2H)-one in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.






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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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