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Document 32018R0242

Commission Implementing Regulation (EU) 2018/242 of 15 February 2018 concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate as feed additives for all animal species (Text with EEA relevance. )

C/2018/0771

OJ L 53, 23.2.2018, p. 36–68 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

ELI: http://data.europa.eu/eli/reg_impl/2018/242/oj

23.2.2018   

EN

Official Journal of the European Union

L 53/36


COMMISSION IMPLEMENTING REGULATION (EU) 2018/242

of 15 February 2018

concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

(1)

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

(2)

The substances, hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate (‘substances concerned’) were authorised without a time limit by 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) 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, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, and on the labelling of feed materials and compound feed.

(6)

The Authority concluded that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)

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

(8)

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

(9)

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 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 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.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 268, 18.10.2003, p. 29.

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

(3)  EFSA Journal 2016;14(8):4559.


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

2b02056

Hex-3(cis)-en-1-ol

Additive composition

Hex-3(cis)-en-1-ol

Characterisation of the active substance

Hex-3(cis)-en-1-ol

Produced by chemical synthesis

Purity: min. 98 % assay as sum of (Z)- and (E)-isomers; min. 92 % of (Z)-isomer

Chemical formula: C6H12O

CAS number: 928-96-1

FLAVIS No: 02.056

Method of analysis  (1)

For the determination of hex-3(cis)-en-1-ol 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b02093

Non-6-en-1-ol

Additive composition

Non-6-en-1-ol

Characterisation of the active substance

Non-6-en-1-ol

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H18O

CAS number: 35854-86-5

FLAVIS No: 02.093

Method of analysis  (1)

For the determination of non-6-en-1-ol 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.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b02094

Oct-3-en-1-ol

Additive composition

Oct-3-en-1-ol

Characterisation of the active substance

Oct-3-en-1-ol

Produced by chemical synthesis

Purity: min. 96 % assay, as (Z)- isomer.

Chemical formula: C8H16O

CAS number: 20125-84-2

FLAVIS No: 02.094

Method of analysis  (1)

For the determination oct-3-en-1-ol 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.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b05059

Non-6(cis)-enal

Additive composition

Non-6(cis)-enal

Characterisation of the active substance

Non-6(cis)-enal

Produced by chemical synthesis

Purity: min. 96 % assay; secondary component 6–9 % trans-6-nonenal

Chemical formula: C9H16O

CAS number: 2277-19-2

FLAVIS No: 05.059

Method of analysis  (1)

For the determination non-6(cis)-enal 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b05075

Hex-3(cis)-enal

Additive composition

Hex-3(cis)-enal

Characterisation of the active substance

Hex-3(cis)-enal

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H10O

CAS number: 6789-80-6

FLAVIS No: 05.075

Method of analysis  (1)

For the determination of hex-3(cis)-enal 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b05085

Hept-4-enal

Additive composition

Hept-4-enal

Characterisation of the active substance

Hept-4-enal

Produced by chemical synthesis

Purity: min. 98 % as sum of (Z)- and (E)-isomers; min. 93 % of (Z)-isomer; secondary component: 2-5 % (E)- isomer.

Chemical formula: C7H12O

CAS number: 6728-31-0

FLAVIS No: 05.085

Method of analysis  (1)

For the determination of hept-4-enal 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b09197

Hex-3(cis)-enyl acetate

Additive composition

Hex-3(cis)-enyl acetate

Characterisation of the active substance

Hex-3(cis)-enyl acetate

Produced by chemical synthesis

Purity: min. 98 % assay as sum of (Z)- and (E)-isomers; min. 92 % of (Z)-isomer

Chemical formula: C8H14O2

CAS number: 3681-71-8

FLAVIS No: 09.197

Method of analysis  (1)

For the determination of hex-3(cis)-enyl 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b09240

Hex-3(cis)-enyl formate

Additive composition

Hex-3(cis)-enyl formate

Characterisation of the active substance

Hex-3(cis)-enyl formate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C7H12O2

CAS number: 33467-73-1

FLAVIS No: 09.240

Method of analysis  (1)

For the determination of hex-3(cis)-enyl formate 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b09270

Hex-3-enyl butyrate

Additive composition

Hex-3-enyl butyrate

Characterisation of the active substance

Hex-3-enyl butyrate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H18O2

CAS number: 16491-36-4

FLAVIS No: 09.270

Method of analysis  (1)

For the determination of hex-3-enyl butyrate 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b09271

Hex-3-enyl hexanoate

Additive composition

Hex-3-enyl hexanoate

Characterisation of the active substance

Hex-3-enyl hexanoate

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C12H22O2

CAS number: 31501-11-8

FLAVIS No: 09.271

Method of analysis  (1)

For the determination of hex-3-enyl hexanoate 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b09563

Hex-3(cis)-enyl isobutyrate

Additive composition

Hex-3(cis)-enyl isobutyrate

Characterisation of the active substance

Hex-3(cis)-enyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C10H18O2

CAS number: 41519-23-7

FLAVIS No: 09.563

Method of analysis  (1)

For the determination of hex-3(cis)-enyl isobutyrate 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.

The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b02011

Citronellol

Additive composition

Citronellol

Characterisation of the active substance

Citronellol

Produced by chemical synthesis

Purity: min. 90 % assay; racemate; other constituents: diunsaturated and saturated C10 alcohols, citronellyl acetate and citronellal

Chemical formula: C10H20O

CAS number: 106-22-9

FLAVIS No: 02.011

Method of analysis  (1)

For the determination of citronellol 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b02229

(-)-3,7-Dimethyl-6-octen-1-ol

Additive composition

(-)-3,7-Dimethyl-6-octen-1-ol

Characterisation of the active substance

(-)-3,7-Dimethyl-6-octen-1-ol

Produced by chemical synthesis or derived by fractional distillation of essential oils and saponification of extracts

Purity: min. 90 % assay

Chemical formula: C10H20O

CAS number: 7540-51-4

FLAVIS No: 02.229

Method of analysis  (1)

For the determination of (-)-3,7-dimethyl-6-octen-1-ol 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b05021

Citronellal

Additive composition

Citronellal

Characterisation of the active substance

Citronellal

Produced by chemical synthesis

Purity: min. 85 % assay.

Chemical formula: C10H18O

CAS number: 106-23-0

FLAVIS No: 05.021

Method of analysis  (1)

For the determination of citronellal 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b05074

2,6-Dimethylhept-5-enal

Additive composition

2,6-Dimethylhept-5-enal

Characterisation of the active substance

2,6-Dimethylhept-5-enal

Produced by chemical synthesis

Purity: min. 85 % assay

Chemical formula: C9H16O

CAS number: 106-72-9

FLAVIS No: 05.074

Method of analysis  (1)

For the determination of 2,6-dimethylhept-5-enal 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b08036

Citronellic acid

Additive composition

Citronellic acid

Characterisation of the active substance

Citronellic acid

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C10H18O2

CAS number: 502-47-6

FLAVIS No: 08.036

Method of analysis  (1)

For the determination of citronellic acid 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b09012

Citronellyl acetate

Additive composition

Citronellyl acetate

Characterisation of the active substance

Citronellyl acetate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C11H22O2

CAS number: 150-84-5

FLAVIS No: 09.012

Method of analysis  (1)

For the determination of citronellyl 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b09049

Citronellyl butyrate

Additive composition

Citronellyl butyrate

Characterisation of the active substance

Citronellyl butyrate

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C14H26O2

CAS number: 141-16-2

FLAVIS No: 09.049

Method of analysis  (1)

For the determination of citronellyl butyrate 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b09078

Citronellyl formate

Additive composition

Citronellyl formate

Characterisation of the active substance

Citronellyl formate

Produced by chemical synthesis

Purity: min. 90 % assay.

Chemical formula: C11H20O2

CAS number: 105-85-1

FLAVIS No: 09.078

Method of analysis  (1)

For the determination of citronellyl formate 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b09129

Citronellyl propionate

Additive composition

Citronellyl propionate

Characterisation of the active substance

Citronellyl propionate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C13H24O2

CAS number: 141-14-0

FLAVIS No: 09.129

Method of analysis  (1)

For the determination of citronellyl propionate 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.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

1 mg/kg for cats

5 mg/kg for other species and categories.

4.

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 for cats

5 mg/kg for other species and categories’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

1 mg/kg for cats

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

2b06081

1-Ethoxy-1-(3-hexenyloxy)ethane

Additive composition

1-Ethoxy-1-(3-hexenyloxy)ethane

Characterisation of the active substance

1-Ethoxy-1-(3-hexenyloxy)ethane

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C10H20O2

CAS number: 28069-74-1

FLAVIS No: 06.081

Method of analysis  (1)

For the determination of 1-ethoxy-1-(3-hexenyloxy)ethane 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.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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

2b09505

Hex-3-enyl isovalerate

Additive composition

Hex-3-enyl isovalerate

Characterisation of the active substance

Hex-3-enyl isovalerate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C11H20O2

CAS number: 10032-11-8

FLAVIS No: 09.505

Method of analysis  (1)

For the determination of hex-3-enyl isovalerate 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.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

4.

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.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in 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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