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Document 32017R0063

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Commission Implementing Regulation (EU) 2017/63 of 14 December 2016 concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species (Text with EEA relevance. )

C/2016/8241

OJ L 13, 17.1.2017, p. 214–241 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg_impl/2017/63/oj

17.1.2017   

EN

Official Journal of the European Union

L 13/214

COMMISSION IMPLEMENTING REGULATION (EU) 2017/63

of 14 December 2016

concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain 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)

Benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, veratraldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, gallic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate (‘substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. Veratraldehyde for poultry and fish and gallic acid for fish will not be re-authorised as they were withdrawn by the applicant.

(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 benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species. The applicant requested 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 13 June 2012 (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 further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority cannot conclude on the safety of the concerned substances in water for drinking. However, those substances can be used 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, except for benzoic acid, and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that in the absence of data the substances concerned should be considered as potentially hazardous to the respiratory tract, skin and eyes, skin sensitisers and harmful if swallowed. 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 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 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, 14 December 2016.

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 2012;10(7):2785.

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 %

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

Category: Sensory additives. Functional group: Flavouring compounds

2b02010

—

Benzyl alcohol

Additive composition

Benzyl alcohol

Characterisation of the active substance

Benzyl alcohol

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H8O

CAS number 100-51-6

FLAVIS No 02.010

Method of analysis  (1)

For the determination of benzyl 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.

The recommended maximum content of the active substance shall be: 125 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 %: 125 mg/kg’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 125 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 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 safety glasses and gloves.

6 February 2027

2b02039

—

4-Isopropylbenzyl alcohol

Additive composition

4-Isopropylbenzyl alcohol

Characterisation of the active substance

4-Isopropylbenzyl alcohol

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C10H14O

CAS number 536-60-7

FLAVIS No 02.039

Method of analysis  (1)

For the determination of 4-isopropylbenzyl 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.

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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b05013

—

Benzaldehyde

Additive composition

Benzaldehyde

Characterisation of the active substance

Benzaldehyde

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C7H6O

CAS number 100-52-7

FLAVIS No 05.013

Method of analysis  (1)

For the determination of benzaldehyde 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: 25 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 %: 25 mg/kg’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b05017

—

Veratraldehyde

Additive composition

Veratraldehyde

Characterisation of the active substance

Veratraldehyde

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C9H10O3

CAS number 120-14-9

FLAVIS No 05.017

Method of analysis  (1)

For the identification of veratraldehyde in the feed additive and flavouring premixtures.

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

All animal species except poultry and fish

—

—

—

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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b05022

—

4-Isopropylbenzaldehyde

Additive composition

4-Isopropylbenzaldehyde

Characterisation of the active substance

4-Isopropylbenzaldehyde

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C10H12O

CAS number 122-03-2

FLAVIS No 05.022

Method of analysis  (1)

For the determination of 4-isopropylbenzaldehyde 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b05055

—

Salicylaldehyde

Additive composition

Salicylaldehyde

Characterisation of the active substance

Salicylaldehyde

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C7H6O2

CAS number 90-02-8

FLAVIS No 05.055

Method of analysis  (1)

For the identification of salicylaldehyde in the feed additive and 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b05029

—

p-Tolualdehyde

Additive composition

p-Tolualdehyde

Characterisation of the active substance

p-Tolualdehyde

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H8O

CAS number 104-87-0

FLAVIS No 05.029

Method of analysis  (1)

For the determination of p-tolualdehyde 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b05129

—

2-Methoxybenzaldehyde

Additive composition

2-Methoxybenzaldehyde

Characterisation of the active substance

2-Methoxybenzaldehyde

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H8O2

CAS number 135-02-4

FLAVIS No 05.129

Method of analysis  (1)

For the identification of 2-methoxybenzaldehyde in the feed additive and 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b08021

—

Benzoic acid

Additive composition

Benzoic acid

Characterisation of the active substance

Benzenecarboxylic acid, phenylcarboxylic acid

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C7H6O2

CAS number 65-85-0

FLAVIS No 08.021

Maximum level of impurities

Phthalic acid: ≤ 100 mg/kg;

Biphenyl: ≤ 100 mg/kg

Method of analysis  (1)

For the determination of benzoic acid in the feed additive and in feed flavouring premixtures.

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

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 and stability conditions shall be indicated.

3.

For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalatory or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

6 February 2027

2b08080

—

Gallic acid

Additive composition

Gallic acid

Characterisation of the active substance

Gallic acid

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C7H6O5

CAS number 149-91-7

FLAVIS No 08.080

Method of analysis  (1)

For the identification of gallic acid in the feed additive and flavouring premixtures.

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

All animal species except fish

—

—

—

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: 25 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 %: 25 mg/kg’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09014

—

Benzyl acetate

Additive composition

Benzyl acetate

Characterisation of the active substance

Benzyl acetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H10O2

CAS number 140-11-4

FLAVIS No 09.014

Method of analysis  (1)

For the determination of benzyl 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: 125 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 %: 125 mg/kg’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 125 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 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 safety glasses and gloves.

6 February 2027

2b09051

—

Benzyl butyrate

Additive composition

Benzyl butyrate

Characterisation of the active substance

Benzyl butyrate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H14O2

CAS number 103-37-7

FLAVIS No 09.051

Method of analysis  (1)

For the determination of benzyl 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09077

—

Benzyl formate

Additive composition

Benzyl formate

Characterisation of the active substance

Benzyl formate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C8H8O2

CAS number 104-57-4

FLAVIS No 09.077

Method of analysis  (1)

For the determination of benzyl 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09132

—

Benzyl propionate

Additive composition

Benzyl propionate

Characterisation of the active substance

Benzyl propionate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C10H12O2

CAS number 122-63-4

FLAVIS No 09.132

Method of analysis  (1)

For the determination of benzyl 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 shall be: 25 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 %: 25 mg/kg’.

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09316

 

Benzyl hexanoate

Additive composition

Benzyl hexanoate

Characterisation of the active substance

Benzyl hexanoate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C13H18O2

CAS number 6938-45-0

FLAVIS No 09.316

Method of analysis  (1)

For the identification of benzyl hexanoate in the feed additive and 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:

for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 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 %:

—

1 mg/kg for pigs and poultry;

—

1,5 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:

—

1 mg/kg for pigs and poultry;

—

1,5 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 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 safety glasses and gloves.

6 February 2027

2b09426

—

Benzyl isobutyrate

Additive composition

Benzyl isobutyrate

Characterisation of the active substance

Benzyl isobutyrate

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C11H14O2

CAS number 103-28-6

FLAVIS No 09.426

Method of analysis  (1)

For the determination of benzyl 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09458

—

Benzyl isovalerate

Additive composition

Benzyl isovalerate

Characterisation of the active substance

Benzyl isovalerate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H16O2

CAS number 103-38-8

FLAVIS No 09.458

Method of analysis  (1)

For the determination of benzyl 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: 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09581

—

Hexyl salicylate

Additive composition

Hexyl salicylate

Characterisation of the active substance

Hexyl salicylate

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C13H18O3

CAS number 6259-76-3

FLAVIS No 09.581

Method of analysis  (1)

For the identification of hexyl salicylate in the feed additive and 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09705

—

Benzyl phenylacetate

Additive composition

Benzyl phenylacetate

Characterisation of the active substance

Benzyl phenylacetate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C15H14O2

CAS number 102-16-9

FLAVIS No 09.705

Method of analysis  (1)

For the determination of benzyl phenylacetate 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09725

—

Methyl benzoate

Additive composition

Methyl benzoate

Characterisation of the active substance

Methyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H8O2

CAS number 93-58-3

FLAVIS No 09.725

Method of analysis  (1)

For the determination of methyl benzoate 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09726

—

Ethyl benzoate

Additive composition

Ethyl benzoate

Characterisation of the active substance

Ethyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H10O2

CAS number 93-89-0

FLAVIS No 09.726

Method of analysis  (1)

For the determination of ethyl benzoate 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09755

—

Isopentyl benzoate

Additive composition

Isopentyl benzoate

Characterisation of the active substance

Isopentyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C12H16O2

CAS number 94-46-2

FLAVIS No 09.755

Method of analysis  (1)

For the determination of isopentyl benzoate 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09762

—

Pentyl salicylate

Additive composition

Pentyl salicylate

Characterisation of the active substance

Pentyl salicylate

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula C12H16O3

CAS number 2050-08-0

FLAVIS No 09.762

Method of analysis  (1)

For the identification of pentyl salicylate in the feed additive and 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

2b09757

—

Isobutyl benzoate

Additive composition

Isobutyl benzoate

Characterisation of the active substance

Isobutyl benzoate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H14O2

CAS number 120-50-3

FLAVIS No 09.757

Method of analysis  (1)

For the determination of isobutyl benzoate 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

6 February 2027

(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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