Commission Implementing Regulation (EU) 2024/1989 of 22 July 2024 concerning the ... (32024R1989)
EU - Rechtsakte: 03 Agriculture
2024/1989
24.7.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/1989

of 22 July 2024

concerning the authorisation of undec-10-enal, terpineol acetate,

d,l

-borneol,

l

-carvone,

d

-camphor,

d,l

-isobornyl acetate, 3-propylidenephthalide, phenylacetic acid, methyl salicylate, thymol, carvacrol, benzothiazole, terpinolene,

d,l

-isoborneol,

trans

-menthone,

d,l

-bornyl acetate, 3-butylidenephthalide, phenylacetaldehyde, phenethyl acetate, phenethyl phenylacetate, methyl phenylacetate, ethyl phenylacetate, isobutyl phenylacetate, 3-methylbutyl phenylacetate, 2-methoxyphenol, 2-methoxy-4-methylphenol, 4-ethylguaiacol, 2-methoxy-4-vinylphenol, 4-ethylphenol, 2-methylphenol, 4-methylphenol, 2,6-dimethoxyphenol, phenol, 2,6-dimethylphenol, 2-isopropylphenol, benzene-1,3-diol, alpha-phellandrene, alpha-terpinene, gamma-terpinene and

l

-limonene as feed additives for all animal species and amending Implementing Regulation (EU) 2018/245 as regards the terms of authorisation of

d,l

-isomenthone as a feed additive 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 Articles 9(2) and 13(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 and modifying 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 undec-10-enal, terpineol acetate,
d,l
-borneol,
l
-carvone,
d
-camphor,
d,l
-isobornyl acetate, 3-propylidenephthalide, phenylacetic acid, methyl salicylate, thymol, carvacrol, benzothiazole, terpinolene,
d,l
-isoborneol,
trans
-menthone,
d,l
-bornyl acetate, 3-butylidenephthalide, phenylacetaldehyde, phenethyl acetate, phenethyl phenylacetate, methyl phenylacetate, ethyl phenylacetate, isobutyl phenylacetate, 3-methylbutyl phenylacetate, 2-methoxyphenol, 2-methoxy-4-methylphenol, 4-ethylguaiacol, 2-methoxy-4-vinylphenol, 4-ethylphenol, 2-methylphenol, 4-methylphenol, 2,6-dimethoxyphenol, phenol, 2,6-dimethylphenol, 2-isopropylphenol, benzene-1,3-diol, alpha-phellandrene, alpha-terpinene, gamma-terpinene and
l
-limonene 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, 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, nine applications were submitted for the authorisation of undec-10-enal, terpineol acetate,
d,l
-borneol,
l
-carvone,
d
-camphor,
d,l
-isobornyl acetate, 3-propylidenephthalide, phenylacetic acid, methyl salicylate, thymol, carvacrol, benzothiazole, terpinolene,
d,l
-isoborneol,
trans
-menthone,
d,l
-bornyl acetate, 3-butylidenephthalide, phenylacetaldehyde, phenethyl acetate, phenethyl phenylacetate, methyl phenylacetate, ethyl phenylacetate, isobutyl phenylacetate, 3-methylbutyl phenylacetate, 2-methoxyphenol, 2-methoxy-4-methylphenol, 4-ethylguaiacol, 2-methoxy-4-vinylphenol, 4-ethylphenol, 2-methylphenol, 4-methylphenol, 2,6-dimethoxyphenol, phenol, 2,6-dimethylphenol, 2-isopropylphenol, benzene-1,3-diol, alpha-phellandrene, alpha-terpinene, gamma-terpinene and
l
-limonene (‘the substances concerned’) 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 substances concerned 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 use of
d,l
-isomenthone as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) 2018/245 (3).
(6) In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority (‘the Authority’) to issue an opinion on whether the authorisation of
d,l
-isomenthone as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, considering a modification of the terms of that authorisation. That modification consists in an increase of the maximum recommended level of
d,l
-isomenthone to 5 mg/kg for all animal species. The request was accompanied by the relevant supporting data.
(7) The Authority concluded in its opinions of 1 February 2012 (4), 6 March 2012 (5), 7 March 2012 (6), 13 June 2012 (7), 13 November 2012 (8), 10 March 2015 (9), 8 March 2016 (10), 20 April 2016 (11),12 July 2016 (12) and 26 September 2023 (13) that, under the proposed conditions of use, the substances concerned are safe for all animal species, consumers and the environment. It stated that for 2-methoxyphenol, thymol, 2-methoxy-4-methylphenol, 4-ethylguaiacol, 2-methoxy-4-vinylphenol, 4-ethylphenol, 2-methylphenol, 4-methylphenol, carvacrol, 2,6-dimethoxyphenol, phenol, 2,6-dimethylphenol, 2-isopropylphenol and benzene-1,3-diol, no new data on the safety for the user was provided but that potential hazards for skin and eye contact and respiratory exposure of various severity are recognised for these substances. For 3-butylidenephthalide and 3-propylidenephthalide, the material safety data sheets provided by the suppliers identify those substances as irritant to skin, eye and the respiratory tract and harmful if swallowed. For phenylacetaldehyde, phenylacetic acid, phenethyl acetate, phenethyl phenylacetate, methyl phenylacetate, ethyl phenylacetate, isobutyl phenylacetate, methyl salicylate and 3-methylbutyl phenylacetate, the Authority considered it prudent to treat all those compounds as irritants to skin, eyes and respiratory tract, skin sensitisers and harmful if swallowed. For terpineol acetate, it considered it prudent to treat it as irritant to skin, eyes and respiratory tract and as skin sensitiser. Terpinolene, alpha-phellandrene, alpha-terpinene, gamma-terpinene and
l
-limonene should be considered irritant to skin, eyes and respiratory tract and as skin sensitisers. The Authority stated that for benzothiazole,
d,l
-borneol,
d,l
-isoborneol,
l
-carvone,
trans
-menthone,
d
-camphor,
d,l
-bornyl acetate, undec-10-enal and
d,l
-isobornyl acetate, hazards for skin and eye contact and respiratory exposure are recognised and that they are classified as irritating to the respiratory system. The Authority finally 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 and therefore that no further demonstration of efficacy is considered necessary. The Authority 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. Furthermore, the Authority concluded in the opinion of 26 September 2023 that for
d,l
-isomenthone, the maximum recommended level of 5 mg/kg is safe for all animal species, consumers and the environment.
(8) In view of the above, the Commission considers that the substances concerned satisfy the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003. In addition, the Commission considers that the authorisation of
d,l
-isomenthone still meets the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, when modifying the terms thereof as regards the increase of the maximum recommended level to 5 mg/kg for all animal species. Accordingly, the use of the substances concerned should be authorised and the terms of authorisation for
d,l
-isomenthone should be modified. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the substances concerned.
(9) The Commission considers that for
l
-carvone, methyl salicylate, thymol and carvacrol, safety reasons require the establishment of maximum contents and that those additives cannot be used in combination with other additives containing such substances. For undec-10-enal, terpineol acetate,
d,l
-borneol,
d
-camphor,
d,l
-isobornyl acetate, 3-propylidenephthalide, phenylacetic acid, benzothiazole, terpinolene,
d,l-
isoborneol,
trans
-menthone,
d,l
-bornyl acetate, 3-butylidenephthalide, phenylacetaldehyde, phenethyl acetate, phenethyl phenylacetate, methyl phenylacetate, ethyl phenylacetate, isobutyl phenylacetate, 3-methylbutyl phenylacetate, 2-methoxyphenol, 2-methoxy-4-methylphenol, 4-ethylguaiacol, 2-methoxy-4-vinylphenol, 4-ethylphenol, 2-methylphenol, 4-methylphenol, 2,6-dimethoxyphenol, phenol, 2,6-dimethylphenol, 2-isopropylphenol, benzene-1,3-diol, alpha-phellandrene, alpha-terpinene, gamma-terpinene and
l
-limonene safety reasons do not require the setting of maximum contents. However, in order to allow better control, a recommended maximum content should be indicated on the label of those additives. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned.
(10) Implementing Regulation (EU) 2018/245 should therefore be amended accordingly.
(11) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation. In addition, since safety reasons do not require the immediate application of the modification to the terms of authorisation for
d,l
-isomenthone, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the requirements resulting from that modification.
(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

Amendment to Implementing Regulation (EU) 2018/245

In the entry for
d,l-
isomenthone in the Annex to Implementing Regulation (EU) 2018/245, points 3 to 5 of the column ‘Other provisions’ are replaced by the following:
‘3.
On the label of the additive, the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg for all animal species’.
‘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 suggested on the label of the premixture would result in exceeding the level referred to in point 3.’
‘5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg for all animal species.’.

Article 3

Transitional measures

1.   The feed additives undec-10-enal, terpineol acetate,
d,l
-borneol,
l
-carvone,
d
-camphor,
d,l
-isobornyl acetate, 3-propylidenephthalide, phenylacetic acid, methyl salicylate, thymol, carvacrol, benzothiazole, terpinolene,
d,l
-isoborneol,
trans
-menthone,
d,l
-bornyl acetate, 3-butylidenephthalide, phenylacetaldehyde, phenethyl acetate, phenethyl phenylacetate, methyl phenylacetate, ethyl phenylacetate, isobutyl phenylacetate, 3-methylbutyl phenylacetate, 2-methoxyphenol, 2-methoxy-4-methylphenol, 4-ethylguaiacol, 2-methoxy-4-vinylphenol, 4-ethylphenol, 2-methylphenol, 4-methylphenol, 2,6-dimethoxyphenol, phenol, 2,6-dimethylphenol, 2-isopropylphenol, benzene-1,3-diol, alpha-phellandrene, alpha-terpinene, gamma-terpinene and
l
-limonene, as authorised pursuant to Directive 70/524/EEC, and the feed additive
d,l
-isomenthone (identification number: 2b07078) authorised by Implementing Regulation (EU) 2018/245, and premixtures containing these feed additives, which are produced and labelled before 13 February 2025 in accordance with the rules applicable before 13 August 2024 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.   Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 13 August 2025 in accordance with the rules applicable before 13 August 2024 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3.   Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 13 August 2026 in accordance with the rules applicable before 13 August 2024 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.

Article 4

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, 22 July 2024.
For the Commission
The President
Ursula VON DER LEYEN
(1)  
OJ L 268, 18.10.2003, p. 29
, ELI:
http://data.europa.eu/eli/reg/2003/1831/oj.
(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (
OJ L 270, 14.12.1970, p. 1
, ELI:
http://data.europa.eu/eli/dir/1970/524/oj
).
(3)  Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate,
d,l
-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one,
d
-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (
OJ L 53, 23.2.2018, p. 87
, ELI:
http://data.europa.eu/eli/reg_impl/2018/245/oj
).
(4)  
EFSA Journal
2012;10(2):2573.
(5)  
EFSA Journal
2012;10(3):2622.
(6)  
EFSA Journal
2012;10(3):2625.
(7)  
EFSA Journal
2012;10(7):2785.
(8)  
EFSA Journal
2012;10(11):2966.
(9)  
EFSA Journal
2015;13(3):4053.
(10)  
EFSA Journal
2016;14(6):4441.
(11)  
EFSA Journal
2016;14(6):4475.
(12)  
EFSA Journal
2016;14(8):4559.
(13)  
EFSA Journal
2023;21(10):8340.

ANNEX

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b05035

Undec-10-enal

Additive composition

Undec-10-enal

Characterisation of active substance

Undec-10-enal

Produced by chemical synthesis

Purity: min. 90 %

Chemical formula: C11H20O

CAS number: 112-45-8

FLAVIS: 05.035

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (1)

For the identification of undec-10-enal in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09830

Terpineol acetate

Additive composition

Terpineol acetate

Characterisation of active substance

Terpineol acetate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C12H20O2

CAS number: 8007-35-0

FLAVIS: 09.830

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 10 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (2)

For the identification of terpineol 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b02016

d,l-Borneol

Additive composition

d,l-Borneol

Characterisation of active substance

d,l-Borneol

Produced by chemical synthesis

Purity: min. 97 % (min. assay value may include isoborneol, other isomers of borneol, trace amounts of fenchyl alcohol and other C10H18O compounds)

Chemical formula: C10H18O

CAS number: 507-70-0

FLAVIS: 02.016

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 %: 15 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (3)

For the identification of d,l-borneol in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b07147

l-Carvone

Additive composition

l-Carvone

Characterisation of active substance

l-Carvone

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C10H14O

CAS number: 6485-40-1

FLAVIS: 07.147

All animal species

10

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.

The additive shall not be used with other sources of l-carvone.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (4)

For the identification of l-carvone in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b07215

d-Camphor

Additive composition

d-Camphor

Characterisation of active substance

d-Camphor (also known as (1R)-1,7,7-Trimethylbicyclo[2.2.1]heptan-2-one)

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C10H16O

CAS number: 464-49-3

FLAVIS: 07.215

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (5)

For the identification of d-camphor in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09218

d,l-Isobornyl acetate

Additive composition

d,l-Isobornyl acetate

Characterisation of active substance

d,l-Isobornyl acetate

Produced by chemical synthesis

Purity: min. 97 % (min. assay value may include small amounts of bornyl acetate)

Chemical formula: C12H20O2

CAS number: 125-12-2

FLAVIS: 09.218

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (6)

For the identification of d,l-isobornyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b10005

3-Propylidenephthalide

Additive composition

3-Propylidenephthalide

Characterisation of active substance

3-Propylidenephthalide

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C11H10O2

CAS number: 17369-59-4

FLAVIS: 10.005

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (7)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b08038

Phenylacetic acid

Additive composition

Phenylacetic acid

Characterisation of active substance

Phenylacetic acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C8H8O2

CAS number: 103-82-2

FLAVIS: 08.038

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 %: 25 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (8)

For the identification of phenylacetic 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09749

Methyl salicylate

Additive composition

Methyl salicylate

Characterisation of active substance

Methyl salicylate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H8O3

CAS number: 119-36-8

FLAVIS: 09.749

All animal species

50

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.

The additive shall not be used with other sources of methyl salicylate.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (9)

For the identification of methyl salicylate 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04006

Thymol

Additive composition

Thymol

Characterisation of active substance

Thymol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H14O

CAS number: 89-83-8

FLAVIS: 04.006

All animal species

125

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.

The additive shall not be used with other sources of thymol.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (10)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04031

Carvacrol

Additive composition

Carvacrol

Characterisation of active substance

Carvacrol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H14O

CAS number: 499-75-2

FLAVIS: 04.031

All animal species

125

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.

The additive shall not be used with other sources of carvacrol.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (11)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b15016

Benzothiazole

Additive composition

Benzothiazole

Characterisation of active substance

Benzothiazole

Produced by chemical synthesis

Purity: min. 96 %

Chemical formula: C7H5NS

CAS number: 95-16-9

FLAVIS: 15.016

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 %: 0,5 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (12)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b01005

Terpinolene

Additive composition

Terpinolene

Characterisation of active substance

Terpinolene

Produced by chemical synthesis or by fractional or steam distillation of essential oils.

Purity: min. 95 %

Chemical formula: C10H16

CAS number: 586-62-9

FLAVIS: 01.005

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 %: 14,5 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (13)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b02059

d,l-Isoborneol

Additive composition

d,l-Isoborneol

Characterisation of active substance

d,l-Isoborneol

Produced by chemical synthesis

Purity: min. 92 % (min. assay value is 92 % and secondary components 3,5 % borneol)

Chemical formula: C10H18O

CAS number: 124-76-5

FLAVIS: 02.059

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (14)

For the identification of d,l-isoborneol in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b07176

trans-Menthone

Additive composition

trans-Menthone

Characterisation of active substance

trans-Menthone

Produced by chemical synthesis

Purity: min. 96 % (sum of two isomers)

Chemical formula: C10H18O

CAS number: 89-80-5

FLAVIS: 07.176

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (15)

For the identification of trans-menthone in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09017

d,l-Bornyl acetate

Additive composition

d,l-Bornyl acetate

Characterisation of active substance

d,l-Bornyl acetate

Produced by chemical synthesis

Purity: min. 98 % (min. assay value is 98 % and may include isobornyl acetate and other bornyl acetate isomers’)

Chemical formula: C12H20O2

CAS number: 76-49-3

FLAVIS: 09.017

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 5 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (16)

For the identification of d,l-bornyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b10024

3-Butylidenephthalide

Additive composition

3-Butylidenephthalide

Characterisation of active substance

3-Butylidenephthalide

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C12H12O2

CAS number: 551-08-6

FLAVIS: 10.024

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (17)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b05030

Phenylacetaldehyde

Additive composition

Phenylacetaldehyde

Characterisation of active substance

Phenyl acetaldehyde

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C8H8O

CAS number: 122-78-1

FLAVIS: 05.030

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (18)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09031

Phenethyl acetate

Additive composition

Phenethyl acetate

Characterisation of active substance

Phenethyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H12O2

CAS number: 103-45-7

FLAVIS: 09.031

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (19)

For the identification of phenethyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09707

Phenethyl phenylacetate

Additive composition

Phenethyl phenylacetate

Characterisation of active substance

Phenethyl phenylacetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C16H16O2

CAS number: 102-20-5

FLAVIS: 09.707

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (20)

For the identification of phenethyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09783

Methyl phenylacetate

Additive composition

Methyl phenylacetate

Characterisation of active substance

Methyl phenylacetate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C9H10O2

CAS number: 101-41-7

FLAVIS: 09.783

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 10 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (21)

For the identification of methyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09784

Ethyl phenylacetate

Additive composition

Ethyl phenylacetate

Characterisation of active substance

Ethyl phenylacetate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C10H12O2

CAS number: 101-97-3

FLAVIS: 09.784

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 10 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (22)

For the identification of ethyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09788

Isobutyl phenylacetate

Additive composition

Isobutyl phenylacetate

Characterisation of active substance

Isobutyl phenylacetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H16O2

CAS number: 102-13-6

FLAVIS: 09.788

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 10 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (23)

For the identification of isobutyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09789

3-Methylbutyl phenylacetate

Additive composition

3-Methylbutyl phenylacetate

Characterisation of active substance

3-Methylbutyl phenylacetate

Produced by chemical synthesis

Purity: min. 97 % (sum of n-amyl and isoamyl esters)

Chemical formula: C13H18O2

CAS number: 102-19-2

FLAVIS: 09.789

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 25 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (24)

For the identification of 3-methylbutyl 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04005

2-Methoxyphenol

Additive composition

2-Methoxyphenol

Characterisation of active substance

2-Methoxyphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H8 O2

CAS number: 90-05-1

FLAVIS: 04.005

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (25)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04007

2-Methoxy-4- methylphenol

Additive composition

2-Methoxy-4-methylphenol

Characterisation of active substance

2-Methoxy-4-methylphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H10O2

CAS number: 93-51-6

FLAVIS: 04.007

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (26)

For the identification of 2-methoxy-4- 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04008

4-Ethylguaiacol

Additive composition

4-Ethylguaiacol

Characterisation of active substance

4-Ethylguaiacol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9 H12 O2

CAS number: 2785-89-9

FLAVIS: 04.008

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (27)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04009

2-Methoxy-4-vinylphenol

Additive composition

2-Methoxy-4-vinylphenol

Characterisation of active substance

2-Methoxy-4-vinylphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H10 O2

CAS number: 7786-61-0

FLAVIS: 04.009

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (28)

For the identification of 2-methoxy-4-vinylphenol in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04022

4-Ethylphenol

Additive composition

4-Ethylphenol

Characterisation of active substance

4-Ethylphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H10 O

CAS number: 123-07-9

FLAVIS: 04.022

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 %: 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (29)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04027

2-Methylphenol

Additive composition

2-Methylphenol

Characterisation of active substance

2-Methylphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H8 O

CAS number: 95-48-7

FLAVIS: 04.027

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 %: 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (30)

For the identification of 2-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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04028

4-Methylphenol

Additive composition

4-Methylphenol

Characterisation of active substance

4-Methylphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H8 O

CAS number: 106-44-5

FLAVIS: 04.028

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (31)

For the identification of 4-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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04036

2,6-Dimethoxyphenol

Additive composition

2,6-Dimethoxyphenol

Characterisation of active substance

2,6-Dimethoxyphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H10O3

CAS number: 91-10-1

FLAVIS: 04.036

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (32)

For the identification of 2,6-dimethoxyphenol in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04041

Phenol

Additive composition

Phenol

Characterisation of active substance

Phenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H6O

CAS number: 108-95-2

FLAVIS: 04.041

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (33)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04042

2,6-Dimethylphenol

Additive composition

2,6-Dimethylphenol

Characterisation of active substance

2,6-Dimethylphenol

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C8H10O

CAS number: 576-26-1

FLAVIS: 04.042

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (34)

For the identification of 2,6-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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04044

2-Isopropylphenol

Additive composition

2-Isopropylphenol

Characterisation of active substance

2-Isopropylphenol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H12O

CAS number: 88-69-7

FLAVIS: 04.044

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (35)

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

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b04047

Benzene-1,3-diol

Additive composition

Benzene-1,3-diol

Characterisation of active substance

Benzene-1,3-diol (also known as resorcinol)

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C6H6O2

CAS number: 108-46-3

FLAVIS: 04.047

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (36)

For the identification of benzene-1,3-diol

in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b01006

alpha-Phellandrene

Additive composition

alpha-Phellandrene

Characterisation of active substance

alpha-Phellandrene

Produced by chemical synthesis or by fractional or steam distillation of essential oils.

Purity: min. 95 %

Chemical formula: C10H16

CAS number: 99-83-2

FLAVIS: 01.006

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (37)

For the identification of alpha-phellandrene in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b01019

alpha-Terpinene

Additive composition

alpha-Terpinene

Characterisation of active substance

alpha-Terpinene

Produced by chemical synthesis or by fractional or steam distillation of essential oils.

Purity: min. 89 %

Chemical formula: C10H16

CAS number: 99-86-5

FLAVIS: 01.019

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (38)

For the identification of alpha-terpinene in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b01020

gamma-Terpinene

Additive composition

gamma-Terpinene

Characterisation of active substance

gamma-Terpinene

Produced by chemical synthesis or by fractional or steam distillation of essential oils.

Purity: min. 95 %

Chemical formula: C10H16

CAS number: 99-85-4

FLAVIS: 01.020

All animal species

1.

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

2.

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

3.

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

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 5 mg.’

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (39)

For the identification of gamma-terpinene in the feed additive and in feed flavouring premixtures:

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

Identification number of the feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b01046

l-Limonene

Additive composition

l-Limonene

Characterisation of active substance

l-Limonene

Produced by chemical synthesis or by fractional or steam distillation of essential oils.

Purity: min. 95 %

Chemical formula: C10H16

CAS number: 5989-54-8

FLAVIS: 01.046

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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

13.8.2034

Analytical method (40)

For the identification of l-Limonene 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
.
(20)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(21)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(22)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(23)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(24)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(25)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(26)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(27)  Details of the analytical methods are available at the following address of the Reference Laboratory:
https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
.
(28)  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
.
(29)  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
.
(30)  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
.
(31)  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
.
(32)  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
.
(33)  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
.
(34)  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
.
(35)  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
.
(36)  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
.
(37)  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
.
(38)  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
.
(39)  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
.
(40)  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
.
ELI: http://data.europa.eu/eli/reg_impl/2024/1989/oj
ISSN 1977-0677 (electronic edition)
Markierungen
Leseansicht