Commission Implementing Regulation (EU) 2023/605 of 9 March 2023 concerning the authorisation of ethyl oleate, nona-2,6-dien-1-ol, pent-2-en-1-ol, trans-2,cis-6-nonadien-1-ol, 2-dodecenal, nona-2(trans),6(cis)-dienal, nona-2,4-dienal, trans-2-nonenal, 2,4-decadienal, hepta-2,4-dienal, deca-2(trans),4(trans)-dienal, dodec-2(trans)-enal, hept-2(trans)-enal, non-2-enal, nona-2(trans),6(trans)-dienal, undec-2(trans)-enal, trans-2-octenal, trans-2-decenal, tr-2, tr-4-nonadienal, tr-2, tr-4-undecadienal, hex-2(trans)-enyl acetate, hex-2-enyl butyrate, oct-1-en-3-one, isopulegol, 4-terpinenol, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, 3-methyl-2-cyclopenten-1-one, methyl 3-oxo-2-pentyl-1-cyclopentylacetate, benzophenone, benzyl cinnamate, ethyl salicylate, 1,2-dimethoxy-4-(prop-1-enyl)-benzene, myrcene and β-ocimene as feed additives for all animal species (Text with EEA relevance)
Date: 2023-03-09
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, flavouring, market approval




L_2023082EN.01000101.xml










21.3.2023   


EN


Official Journal of the European Union


L 82/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2023/605
of 9 March 2023
         
concerning the authorisation of ethyl oleate, nona-2,6-dien-1-ol, pent-2-en-1-ol, trans-2,cis-6-nonadien-1-ol, 2-dodecenal, nona-2(trans),6(cis)-dienal, nona-2,4-dienal, trans-2-nonenal, 2,4-decadienal, hepta-2,4-dienal, deca-2(trans),4(trans)-dienal, dodec-2(trans)-enal, hept-2(trans)-enal, non-2-enal, nona-2(trans),6(trans)-dienal, undec-2(trans)-enal, trans-2-octenal, trans-2-decenal, tr-2, tr-4-nonadienal, tr-2, tr-4-undecadienal, hex-2(trans)-enyl acetate, hex-2-enyl butyrate, oct-1-en-3-one, isopulegol, 4-terpinenol, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, 3-methyl-2-cyclopenten-1-one, methyl 3-oxo-2-pentyl-1-cyclopentylacetate, benzophenone, benzyl cinnamate, ethyl salicylate, 1,2-dimethoxy-4-(prop-1-enyl)-benzene, myrcene and β-ocimene 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 oleate, nona-2,6-dien-1-ol, pent-2-en-1-ol, trans-2,cis-6-nonadien-1-ol, 2-dodecenal, nona-2(trans),6(cis)-dienal, nona-2,4-dienal, trans-2-nonenal, 2,4-decadienal, hepta-2,4-dienal, deca-2(trans),4(trans)-dienal, dodec-2(trans)-enal, hept-2(trans)-enal, non-2-enal, nona-2(trans),6(trans)-dienal, undec-2(trans)-enal, trans-2-octenal, trans-2-decenal, tr-2, tr-4-nonadienal, tr-2, tr-4-undecadienal, hex-2(trans)-enyl acetate, hex-2-enyl butyrate, oct-1-en-3-one, isopulegol, 4-terpinenol, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, 3-methyl-2-cyclopenten-1-one, methyl 3-oxo-2-pentyl-1-cyclopentylacetate, benzophenone, benzyl cinnamate, ethyl salicylate, 1,2-dimethoxy-4-(prop-1-enyl)-benzene, myrcene and β-ocimene 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 25 April 2012 (3), 13 June 2012 (4), 13 November 2012 (5), 12 March 2013 (6), 1 December 2015 (7), 20 April 2016 (8), 28 February 2019 (9), 10 January 2020 (10), 28 January 2020 (11) and 23 March 2022 (12) that, under the proposed conditions of use, the substances do not have adverse effects on animal health, consumer safety or the environment. In the absence of relevant studies, the Authority could not conclude on the safety for the users when handling the additives concerned, or concluded that the substances should be considered as irritants to skin and eyes and as potential skin and respiratory sensitisers.












(6)


The Authority concluded that all the substances concerned 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.












(7)


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












(8)


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












(9)


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












(10)


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.












(11)


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 10 October 2023 in accordance with the rules applicable before 10 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 10 April 2024 in accordance with the rules applicable before 10 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 10 April 2025 in accordance with the rules applicable before 10 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, 9 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(5):2678.

(4)  
            EFSA Journal 2012;10(7):2785.

(5)  
            EFSA Journal 2012;10(11):2966.

(6)  
            EFSA Journal 2013;11(4):3169.

(7)  
            EFSA Journal 2016;14(1):4339.

(8)  
            EFSA Journal 2016;14(6):4475.

(9)  
            EFSA Journal 2019;17(3):5654.

(10)  
            EFSA Journal 2020;18(2):6002.

(11)  
            EFSA Journal 2020;18(2):6017.

(12)  
            EFSA Journal 2022;20(4):7249.




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






2b09192


Ethyl oleate



Additive composition

Ethyl oleate

Characterisation of active substance

Ethyl oleate
Produced by chemical synthesis
Purity: ≥ 60 %
Chemical formula: C20H38O2

CAS number: 111-62-6
FLAVIS number: 09.192

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:






—


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






All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b02049


Nona-2,6-dien-1-ol



Additive composition

Nona-2,6-dien-1-ol

Characterisation of active substance

Nona-2,6-dien-1-ol
Produced by chemical synthesis
Purity: ≥ 95 %
Chemical formula: C9H16O
CAS number: 7786-44-9
FLAVIS number: 02.049

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b02050


Pent-2-en-1-ol



Additive composition

Pent-2-en-1-ol

Characterisation of active substance

Pent-2-en-1-ol
Produced by chemical synthesis
Purity: ≥ 95 %
Chemical formula: C5H10O
CAS number: 20273-24-9
FLAVIS number: 02.050

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b02231


Trans-2,cis-6-Nonadien-1-ol



Additive composition

Trans-2,cis-6-Nonadien-1-ol

Characterisation of active substance

trans-2,cis-6-Nonadien-1-ol
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C9H16O
CAS number: 28069-72-9
FLAVIS number: 02.231

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05037


2-Dodecenal



Additive composition

2-Dodecenal

Characterisation of active substance

2-Dodecenal
Produced by chemical synthesis
Purity: ≥ 93 %
Chemical formula: C12H22O
CAS number: 4826-62-4
FLAVIS number: 05.037

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05058


Nona-2(trans),6(cis)-dienal



Additive composition

Nona-2(trans),6(cis)-dienal

Characterisation of active substance

Nona-2(trans),6(cis)-dienal
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C9H14O
CAS number: 557-48-2
FLAVIS number: 05.058

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05071


Nona-2,4-dienal



Additive composition

Nona-2,4-dienal

Characterisation of active substance

Nona-2,4-dienal
Produced by chemical synthesis
Purity: ≥ 89 %
Chemical formula: C9H14O
CAS number: 6750-03-4
FLAVIS number: 05.071

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05072


Trans-2-nonenal



Additive composition

Trans-2-nonenal

Characterisation of active substance

Trans-2-nonenal
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C9H16O
CAS number: 18829-56-6
FLAVIS number: 05.072

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05081


2,4-Decadienal



Additive composition

2,4-Decadienal

Characterisation of active substance

2,4-Decadienal
Produced by chemical synthesis
Purity: ≥ 89 %
Chemical formula: C10H16O
CAS number: 2363-88-4
FLAVIS number: 05.081

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05084


Hepta-2,4-dienal



Additive composition

Hepta-2,4-dienal

Characterisation of active substance

Hepta-2,4-dienal
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C7H10O
CAS number: 4313-03-5
FLAVIS number: 05.084

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05140


Deca-2(trans),4(trans)-dienal



Additive composition

Deca-2(trans),4(trans)-dienal

Characterisation of active substance

Deca-2(trans),4(trans)-dienal
Produced by chemical synthesis
Purity: ≥ 89 %
Chemical formula: C10H16O
CAS number: 25152-84-5
FLAVIS number: 05.140

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05144


Dodec-2(trans)-enal



Additive composition

Dodec-2(trans)-enal

Characterisation of active substance

Dodec-2(trans)-enal
Produced by chemical synthesis
Purity: ≥ 89 %
Chemical formula: C12H22O
CAS number: 20407-84-5
FLAVIS number: 05.144

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05150


Hept-2(trans)-enal



Additive composition

Hept-2(trans)-enal

Characterisation of active substance

Hept-2(trans)-enal
Produced by chemical synthesis
Purity: ≥ 97 %
Chemical formula: C7H12O
CAS number: 18829-55-5
FLAVIS number: 05.150

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05171


Non-2-enal



Additive composition

Non-2-enal

Characterisation of active substance

Non-2-enal
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C9H16O
CAS number: 2463-53-8
FLAVIS number: 05.171

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05172


Nona-2(trans),6(trans)-dienal



Additive composition

Nona-2(trans),6(trans)-dienal

Characterisation of active substance

Nona-2(trans),6(trans)-dienal
Produced by chemical synthesis
Purity: ≥ 97 %
Chemical formula: C9H14O
CAS number: 17587-33-6
FLAVIS number: 05.172

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05184


Undec-2(trans)-enal



Additive composition

Undec-2(trans)-enal

Characterisation of active substance

Undec-2(trans)-enal
Produced by chemical synthesis
Purity: ≥ 95 %
Chemical formula: C11H20O
CAS number: 53448-07-0
FLAVIS number: 05.184

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05190


Trans-2-Octenal



Additive composition

Trans-2-Octenal

Characterisation of active substance

Trans-2-Octenal
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C8H14O
CAS number: 2548-87-0
FLAVIS number: 05.190

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05191


Trans-2-Decenal



Additive composition

Trans-2-Decenal

Characterisation of active substance

Trans-2-Decenal
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C10H18O
CAS number: 3913-81-3
FLAVIS number: 05.191

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05194


tr-2, tr-4-Nonadienal



Additive composition

tr-2, tr-4-Nonadienal

Characterisation of active substance

tr-2, tr-4-Nonadienal
Produced by chemical synthesis
Purity: ≥ 89 %
Chemical formula: C9H14O
CAS number: 5910-87-2
FLAVIS number: 05.194

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b05196


tr-2, tr-4-Undecadienal



Additive composition

tr-2, tr-4-Undecadienal

Characterisation of active substance

tr-2, tr-4-Undecadienal
Produced by chemical synthesis
Purity: ≥ 91 %
Chemical formula: C11H18O
CAS number: 30361-29-6
FLAVIS number: 05.196

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b09394


Hex-2(trans)-enyl acetate



Additive composition

Hex-2(trans)-enyl acetate

Characterisation of active substance

Hex-2(trans)-enyl acetate
Produced by chemical synthesis
Purity: ≥ 90 %
Chemical formula: C8H14O2

CAS number: 2497-18-9
FLAVIS number: 09.394

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b09396


Hex-2-enyl butyrate



Additive composition

Hex-2-enyl butyrate

Characterisation of active substance

Hex-2-enyl butyrate
Produced by chemical synthesis
Purity: ≥ 90 %
Chemical formula: C10H18O2

CAS number: 53398-83-7
FLAVIS number: 09.396

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b07081


Oct-1-en-3-one



Additive composition

Oct-1-en-3-one

Characterisation of active substance

Oct-1-en-3-one
Produced by chemical synthesis
Purity: ≥ 96 %
Chemical formula: C8H14O
CAS number: 4312-99-6
FLAVIS number: 07.081

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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 %:






—


all animal species except cats: 1 mg










—


cats: 0,6 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.






10 April 2033




2b02067


Isopulegol



Additive composition

Isopulegol

Characterisation of active substance

Isopulegol
Produced by chemical synthesis
Purity: ≥ 95 %
Chemical formula: C10H18O
CAS number: 89-79-2
FLAVIS number: 02.067

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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 %:






—


all animal species except cats: 5 mg










—


cats: 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.






10 April 2033




2b02072


4-Terpinenol



Additive composition

4-Terpinenol

Characterisation of active substance

4-Terpinenol
Produced by chemical synthesis
Purity: ≥ 96 %
Chemical formula: C10H18O
CAS number: 562-74-3
FLAVIS number: 02.072

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b09050


Linalyl butyrate



Additive composition

Linalyl butyrate

Characterisation of active substance

Linalyl butyrate
Produced by chemical synthesis
Purity: ≥ 95 %
Chemical formula: C14H24O2

CAS number: 78-36-4
FLAVIS number: 09.050

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b09080


Linalyl formate



Additive composition

Linalyl formate

Characterisation of active substance

Linalyl formate
Produced by chemical synthesis
Purity: ≥ 90 %
Chemical formula: C11H18O2

CAS number: 115-99-1
FLAVIS number: 09.080

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b09130


Linalyl propionate



Additive composition

Linalyl propionate

Characterisation of active substance

Linalyl propionate
Produced by chemical synthesis
Purity: ≥ 92 %
Chemical formula: C13H22O2

CAS number: 144-39-8
FLAVIS number: 09.130

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b09423


Linalyl isobutyrate



Additive composition

Linalyl isobutyrate

Characterisation of active substance

Linalyl isobutyrate
Produced by chemical synthesis
Purity: ≥ 95 %
Chemical formula: C14H24O2

CAS number: 78-35-3
FLAVIS number: 09.423

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b07112


3-Methyl-2-cyclopenten-1-one



Additive composition

3-Methyl-2-cyclopenten-1-one

Characterisation of active substance

3-Methyl-2-cyclopenten-1-one
Produced by chemical synthesis
Purity: ≥ 98 %
Chemical formula: C6H8O
CAS number: 2758-18-1
FLAVIS number: 07.112

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


 








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.










—


ruminants, non-food producing animals and animals farmed in land-based aquaculture systems: 0,5 mg.










—


other species or categories of animals: 0,3 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.






10 April 2033




2b09520


Methyl 3-oxo-2-pentyl-1-cyclopentylacetate



Additive composition

Methyl 3-oxo-2-pentyl-1-cyclopentylacetate

Characterisation of active substance

Methyl 3-oxo-2-pentyl-1-cyclopentylacetate
Produced by chemical synthesis
Purity: ≥ 85 %
Chemical formula: C13H22O3

CAS number: 24851-98-7
FLAVIS number: 09.520

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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: 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.






10 April 2033




2b07032


Benzophenone



Additive composition

Benzophenone

Characterisation of active substance

Benzophenone
Produced by chemical synthesis
Purity: ≥ 98 %
Chemical formula: C13H10O
CAS number: 119-61-9
FLAVIS number: 07.032

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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 %:






—


all animal species except chickens for fattening, laying hens and piglets: 1 mg










—


chickens for fattening, laying hens and piglets: 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.






10 April 2033




2b09739


Benzyl cinnamate



Additive composition

Benzyl cinnamate

Characterisation of active substance

Benzyl cinnamate
Produced by chemical synthesis
Purity: ≥ 98 %
Chemical formula: C16H14O2

CAS number: 103-41-3
FLAVIS number: 09.739

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b09748


Ethyl salicylate



Additive composition

Ethyl salicylate

Characterisation of active substance

Ethyl salicylate
Produced by chemical synthesis
Purity: ≥ 98 %
Chemical formula: C9H10O3

CAS number: 118-61-6
FLAVIS number: 09.748

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b04013


1,2-Dimethoxy-4-(prop-1-enyl)-benzene



Additive composition

1,2-Dimethoxy-4-(prop-1-enyl)-benzene

Characterisation of active substance

1,2-Dimethoxy-4-(prop-1-enyl)-benzene
Produced by chemical synthesis
Purity: ≥ 95 %
Chemical formula: C11H14O2

CAS number: 93-16-3
FLAVIS number: 04.013

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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.






10 April 2033




2b01008


Myrcene



Additive composition

Myrcene

Characterisation of active substance

Myrcene
Produced by chemical synthesis
Purity: ≥ 90 %
Chemical formula: C10H16

CAS number: 123-35-3
FLAVIS number: 01.008

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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 %:






—


all animal species except cats: 5 mg










—


cats: 4 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.






10 April 2033




2b01018


β-Ocimene



Additive composition

β-Ocimene

Characterisation of active substance

β-Ocimene
Produced by chemical synthesis
Purity: ≥ 80 %
Chemical formula: C10H16

CAS number: 13877-91-3
FLAVIS number: 01.018

Analytical method
 (1)

For the identification of the additive in mixtures of flavourings:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


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










2.


In the directions for use of the additive and premixtures, the storage 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 %:






—


all animal species except cats: 5 mg










—


cats: 4 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.






10 April 2033






(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