COMMISSION IMPLEMENTING REGULATION (EU) 2020/1510

of 16 October 2020

concerning the authorisation of cinnamyl alcohol, 3-phenylpropan-1-ol, 2-phenylpropanal, 3-(p-cumenyl)-2-methylpropionalde-hyde, alpha-methylcinnamaldehyde, 3-phenylpropanal, cinnamic acid, cinnamyl acetate, cinnamyl butyrate, 3-phenylpropyl isobutyrate, cinnamyl isovalerate, cinnamyl isobutyrate, ethyl cinnamate, methyl cinnamate and isopentyl cinnamate as feed additives for all animal species except for marine animals

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

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

(2) The substances cinnamyl alcohol, 3-phenylpropan-1-ol, 2-phenylpropanal, 3-(p-cumenyl)-2-methylpropionalde-hyde, alpha-methylcinnamaldehyde, 3-phenylpropanal, cinnamic acid, cinnamyl acetate, cinnamyl butyrate, 3-phenylpropyl isobutyrate, cinnamyl isovalerate, cinnamyl isobutyrate, ethyl cinnamate, methyl cinnamate and isopentyl cinnamate (‘substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. 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 6 December 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 concluded that for the marine environment, the safe use level is estimated to be 0,05 mg/kg feed. The levels of use proposed for the substances concerned exceed the safe level for the marine environment, therefore, the use for marine animals is not authorised. The Authority also concluded in the opinion that the substances concerned are efficacious when used in food, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, However, the substances concerned can be used within compound feeds which are subsequently administered via water.

(5) The Authority concluded that hazards for the skin, eye contact and respiratory exposure are recognised. Most of the substances concerned 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.

(6) 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.

(7) 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.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to 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 8 May 2021 in accordance with the rules applicable before 8 November 2020 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 8 November 2021 in accordance with the rules applicable before 8 November 2020 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 8 November 2022 in accordance with the rules applicable before 8 November 2020 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, 16 October 2020.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 268, 18.10.2003, p. 29

(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (

OJ L 270, 14.12.1970, p. 1

(3)

EFSA Journal

2017;15(1):4672.

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

2b02017

Cinnamyl alcohol

Additive composition

Cinnamyl alcohol

Characterisation of the active substance

Cinnamyl alcohol

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H10O

CAS number: 104-54-1

FLAVIS No: 02.017

Method of analysis (1)

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

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

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.

8.11.2030

2b02031

3-Phenylpropan-1-ol

Additive composition

3-Phenylpropan-1-ol

Characterisation of the active substance

3-Phenylpropan-1-ol

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H12O

CAS number: 122-97-4

FLAVIS No: 02.031

Method of analysis (1)

For the determination 3-phenylpropan-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 except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b05038

2-Phenylpropanal

Additive composition

2-Phenylpropanal

Characterisation of the active substance

2-Phenylpropanal

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C9H10O

CAS number: 93-53-8

FLAVIS No: 05.038

Method of analysis (1)

For the determination 2-phenylpropanal in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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 cats: 1 mg/kg, and for other species and categories: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

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.’

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded:

—	1 mg/kg for cats;

—	5 mg/kg for other species and categories.

8.11.2030

2b05045

3-(p-Cumenyl)-2-methylpropionalde-hyde

Additive composition

3-(p-Cumenyl)-2-methylpropionalde-hyde

Characterisation of the active substance

3-(p-Cumenyl)-2-methylpropionalde-hyde

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C13H18O

CAS number: 103-95-7

FLAVIS No: 05.045

Method of analysis (1)

For the determination of 3-(p-Cumenyl)-2-methylpropionalde-hyde in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b05050

Alpha-methylcinnamaldehyde

Additive composition

Alpha-methylcinnamaldehyde

Characterisation of the active substance

Alpha-methylcinnamaldehyde

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H10O

CAS number: 101-39-3

FLAVIS No: 05.050

Method of analysis (1)

For the determination of alpha-methylcinnamaldehyde in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b05080

3-Phenylpropanal

Additive composition

3-Phenylpropanal

Characterisation of the active substance

3-Phenylpropanal

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C9H10O

CAS number:104-53-0

FLAVIS No: 05.080

Method of analysis (1)

For the determination of 3-phenylpropanal in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b08022

Cinnamic acid

Additive composition

Cinnamic acid

Characterisation of the active substance

Cinnamic acid

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H8O2

CAS number: 621-82-9

FLAVIS No: 08.022

Method of analysis (1)

For the determination of cinnamic acid in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09018

Cinnamyl acetate

Additive composition

Cinnamyl acetate

Characterisation of the active substance

Cinnamyl acetate

Produced by chemical synthesis

Purity: min.98 % assay

Chemical formula: C11H12O2

CAS number: 103-54-8

FLAVIS No: 09.018

Method of analysis (1)

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

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09053

Cinnamyl butyrate

Additive composition

Cinnamyl butyrate

Characterisation of the active substance

Cinnamyl butyrate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C13H16O2

CAS number: 103-61-7

FLAVIS No: 09.053

Method of analysis (1)

For the determination of cinnamyl butyrate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09428

3-Phenylpropyl isobutyrate

Additive composition

3-Phenylpropyl isobutyrate

Characterisation of the active substance

3-Phenylpropyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C13H18O2

CAS number: 103-58-2

FLAVIS No: 09.428.

Method of analysis (1)

For the determination of 3-phenylpropyl isobutyrate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09459

Cinnamyl isovalerate

Additive composition

Cinnamyl isovalerate

Characterisation of the active substance

Cinnamyl isovalerate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C14H18O2

CAS number: 140-27-2

FLAVIS No: 09.459

Method of analysis (1)

For the determination of cinnamyl isovalerate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09470

Cinnamyl isobutyrate

Additive composition

Cinnamyl isobutyrate

Characterisation of the active substance

Cinnamyl isobutyrate

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C13H16O2

CAS number: 103-59-3

FLAVIS No: 09.470

Method of analysis (1)

For the determination of cinnamyl isobutyrate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09730

Ethyl cinnamate

Additive composition

Ethyl cinnamate

Characterisation of the active substance

Ethyl cinnamate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C11H12O2

CAS number: 103-36-6

FLAVIS No: 09.730

Method of analysis (1)

For the determination of ethyl cinnamate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09740

Methyl cinnamate

Additive composition

Methyl cinnamate

Characterisation of the active substance

Methyl cinnamate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C10H10O2

CAS number: 103-26-4

FLAVIS No: 09.740

Method of analysis (1)

For the determination of methyl cinnamate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

2b09742

Isopentyl cinnamate

Additive composition

Isopentyl cinnamate

Characterisation of the active substance

Isopentyl cinnamate

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C14H18O2

CAS number: 7779-65-9

FLAVIS No: 09.742

Method of analysis (1)

For the determination of isopentyl cinnamate in the feed additive and in feed flavouring premixtures:

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

All animal species except marine animals

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, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: 5 mg/kg

8.11.2030

(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