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Document 02018R0245-20240813

Consolidated text: 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 (Text with EEA relevance)

ELI: http://data.europa.eu/eli/reg_impl/2018/245/2024-08-13

02018R0245 — EN — 13.08.2024 — 001.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

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

(Text with EEA relevance)

(OJ L 053 23.2.2018, p. 87)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) 2024/1989 of 22 July 2024

  L 1989

1

24.7.2024




▼B

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

(Text with EEA relevance)



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 feed additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.  
The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
2.  
Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3.  
Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.




ANNEX



Identification number of the additive

Name of the holder of authorisation

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

2b02015

Menthol

Additive composition

Menthol

Characterisation of the active substance

Menthol

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H20O

CAS number: 89-78-1

FLAVIS No: 02.015

Method of analysis (1)

For the determination of menthol in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %: 25 mg/kg.’

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: 25 mg/kg

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07146

d-Carvone

Additive composition

d-Carvone

Characterisation of the active substance

d-Carvone

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H14O

CAS number: 2244-16-8

FLAVIS No: 07.146

Method of analysis (1)

For the determination of d-carvone in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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.’

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

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09016

Menthyl acetate

Additive composition

Menthyl acetate

Characterisation of the active substance

Menthyl acetate

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C12H22O2

CAS number: 29066-34-0

FLAVIS No: 09.016

Method of analysis (1)

For the determination of menthyl acetate in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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.’

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

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07078

d,l-Isomenthone

Additive composition

d,l-Isomenthone

Characterisation of the active substance

d,l-Isomenthone

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C10H18O

CAS number: 491-07-6

FLAVIS No: 07.078

Method of analysis (1)

For the determination of d,l-isomenthone in the feed additive and in feed flavouring premixtures:

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

All animal species

1.  The additive shall be incorporated into the feed in the form of a premixture.
2.  In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. ►M1  
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.  ◄
6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07094

3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

Additive composition

3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

Characterisation of the active substance

3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C11H16O

CAS number: 488-10-8

FLAVIS No: 07.094

Method of analysis (1)

For the determination of 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %:

— 0,3 mg/kg for pigs and poultry;

— 0,5 mg/kg for other species and categories.’

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 levels 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:

— 0,3 mg/kg for pigs and poultry;

— 0,5 mg/kg for other species and categories.

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07126

3,5,5-Trimethylcyclohex-2-en-1-one

Additive composition

3,5,5-Trimethylcyclohex-2-en-1-one

Characterisation of the active substance

3,5,5-Trimethylcyclohex-2-en-1-one

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H14O

CAS number: 78-59-1

FLAVIS No: 07.126

Method of analysis (1)

For the determination of 3,5,5-trimethylcyclohex-2-en-1-one in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %:

— 0,3 mg/kg for pigs and poultry;

— 0,5 mg/kg for other species and categories.’

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 levels 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:

— 0,3 mg/kg for pigs and poultry;

— 0,5 mg/kg for other species and categories

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and glove.

15.3.2028

2b07159

d-Fenchone

Additive composition

d-Fenchone

Characterisation of the active substance

d-Fenchone

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C10H16O

CAS number: 4695-62-9

FLAVIS No: 07.159

Method of analysis (1)

For the determination of d-fenchone in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %:

— 0,3 mg/kg for pigs and poultry;

— 0,5 mg/kg for other species and categories.’

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 levels 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:

— 0,3 mg/kg for pigs and poultry;

— 0,5 mg/kg for other species and categories

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves

15.3.2028

2b02038

Fenchyl alcohol

Additive composition

Fenchyl alcohol

Characterisation of the active substance

Fenchyl alcohol

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C10H18O

CAS number: 1632-73-1

FLAVIS No: 02.038

Method of analysis (1)

For the determination of fenchyl alcohol in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %: 1 mg/kg.’

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: 1 mg/kg

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09215

Carvyl acetate

Additive composition

Carvyl acetate

Characterisation of the active substance

Carvyl acetate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C12H18O2

CAS number: 97-42-7

FLAVIS No: 09.215

Method of analysis (1)

For the determination of carvyl acetate in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %: 1 mg/kg.’

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: 1 mg/kg.

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09216

Dihydrocarvyl acetate

Additive composition

Dihydrocarvyl acetate

Characterisation of the active substance

Dihydrocarvyl acetate

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C12H20O2

CAS number: 20777-49-5

FLAVIS No: 09.216

Method of analysis (1)

For the determination of dihydrocarvyl acetate in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %: 1 mg/kg.’

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: 1 mg/kg

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09269

Fenchyl acetate

Additive composition

Fenchyl acetate

Characterisation of the active substance

Fenchyl acetate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C12H20O2

CAS number: 13851-11-1

FLAVIS No: 09.269

Method of analysis (1)

For the determination of fenchyl acetate in the feed additive and in feed flavouring premixtures:

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

All animal species

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

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

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 %: 1 mg/kg.’

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: 1 mg/kg

6.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

(1)   

Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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