19.10.2020 |
EN |
Official Journal of the European Union |
L 344/2 |
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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 |
- |
- |
- |
|
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