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Document 32020R1396

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Commission Implementing Regulation (EU) 2020/1396 of 5 October 2020 concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals (Text with EEA relevance)

C/2020/6710

OJ L 324, 6.10.2020, p. 6–18 (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/2020/1396/oj

Date of document:: 05/10/2020; Date of adoption
Date of effect:: 26/10/2020; Entry into force Date pub. +20 See Art 3
Deadline:: 26/04/2021; See Art 2.1
Deadline:: 26/10/2021; See Art 2.2
Deadline:: 26/10/2022; See Art 2.3
Date of end of validity:: No end date

Author:: European Commission, Directorate-General for Health and Food Safety
Responsible body:: Directorate-General for Health and Food Safety, SANTE
Form:: Implementing regulation
Additional information:: EEA relevance

Treaty:

Treaty on the Functioning of the European Union

Legal basis:

32003R1831 - A09P2

Link

Select all documents mentioning this document

Instruments cited:

31970L0524

Link

EUROVOC descriptor:

Subject matter:

Directory code:

03.50.10.00 Agriculture / Approximation of laws and health measures / Animal feedingstuffs

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Official Journal

6.10.2020

Official Journal of the European Union

L 324/6

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1396

of 5 October 2020

concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate 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 geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those additives substances 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’. The 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 25 May 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 exceeds the safe level for the marine environment, therefore, the use for marine animals is not authorised. The Authority also concluded in the opinion that, since the substances concerned are efficacious when used as flavourings in food and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion could be extrapolated to feed. Although the applicant withdrew the application for water for drinking, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water.

(5)

The Authority concluded that in the absence of data the substances concerned should be considered hazardous for the skin, and eye contact and for respiratory exposure. Geraniol, citral and 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, are also reported to be skin sensitisers. 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 the substances concerned 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 feed 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 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

2. Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 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. Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 26 October 2022 in accordance with the rules applicable before 26 October 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, 5 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 2016;14(6):4512.

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

2b02012

Geraniol

Additive composition

Geraniol

Characterisation of the active substance

Geraniol

Produced by fractional distillation of an essential oil or by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H18O

CAS number: 106-24-1

FLAVIS No: 02.012

Method of analysis (1)

For the determination of geraniol 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 of flavourings.

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 label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 25 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.

26.10.2030

2b02029

3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

Additive composition

3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

Characterisation of the active substance

3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C15H26O

CAS number: 4602-84-0

FLAVIS No: 02.029

Method of analysis (1)

For the determination of 3,7,11-Trimethyldodeca-2,6,10-trien-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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b02058

(Z)-Nerol

Additive composition

(Z)-Nerol

Characterisation of the active substance

(Z)-Nerol

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H18O

CAS number: 106-25-2

FLAVIS No: 02.058

Method of analysis (1)

For the determination of (Z)-nerol 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b05020

Citral

Additive composition

Citral

Characterisation of the active substance

Citral

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C10H16O

CAS number: 5392-40-5

FLAVIS No: 05.020

Method of analysis (1)

For the determination of citral 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 of flavourings.

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 label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 25 mg/kg.

26.10.2030

2b09011

Geranyl acetate

Additive composition

Geranyl acetate

Characterisation of the active substance

Geranyl acetate

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C12H20O2

CAS number: 105-87-3

FLAVIS No: 09.011

Method of analysis (1)

For the determination of geranyl 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09048

Geranyl butyrate

Additive composition

Geranyl butyrate

Characterisation of the active substance

Geranyl butyrate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C14H24O2

CAS number: 106-29-6

FLAVIS No: 09.048

Method of analysis (1)

For the determination of geranyl 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09076

Geranyl formate

Additive composition

Geranyl formate

Characterisation of the active substance

Geranyl formate

Produced by chemical synthesis

Purity: min. 94 % assay

Chemical formula: C11H18O2

CAS number: 105-86-2

FLAVIS No: 09.076

Method of analysis (1)

For the determination of geranyl formate 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09128

Geranyl propionate

Additive composition

Geranyl propionate

Characterisation of the active substance

Geranyl propionate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C13H22O2

CAS number: 105-90-8

FLAVIS No: 09.128

Method of analysis (1)

For the determination of geranyl propionate 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09169

Neryl propionate

Additive composition

Neryl propionate

Characterisation of the active substance

Neryl propionate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C13H22O2

CAS number: 105-91-9

FLAVIS No: 09.169

Method of analysis (1)

For the determination of neryl propionate 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 %exceeds 5 mg/kg.

26.10.2030

2b09212

Neryl formate

Additive composition

Neryl formate

Characterisation of the active substance

Neryl formate

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C11H18O2

CAS number: 2142-94-1

FLAVIS No: 09.212

Method of analysis (1)

For the determination of neryl formate 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09213

Neryl acetate

Additive composition

Neryl acetate

Characterisation of the active substance

Neryl acetate

Produced by chemical synthesis

Purity: min. 93 % assay

Chemical formula: C12H20O2

CAS number: 141-12-8

FLAVIS No: 09.213

Method of analysis (1)

For the determination of neryl 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 of flavourings.

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.’

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09424

Neryl isobutyrate

Additive composition

Neryl isobutyrate

Characterisation of the active substance

Neryl isobutyrate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C14H24O2

CAS number: 2345-24-6

FLAVIS No: 09.424

Method of analysis (1)

For the determination of neryl 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09431

Geranyl isobutyrate

Additive composition

Geranyl isobutyrate

Characterisation of the active substance

Geranyl isobutyrate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C14H24O2

CAS number: 2345-26-8

FLAVIS No: 09.431

Method of analysis (1)

For the determination of geranyl 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 of flavourings.

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 content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 5 mg/kg.

26.10.2030

2b09692

Prenyl acetate

Additive composition

Prenyl acetate

Characterisation of the active substance

Prenyl acetate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C7H12O2

CAS number: 1191-16-8

FLAVIS No: 09.692

Method of analysis (1)

For the determination of prenyl 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 of flavourings.

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

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

4.	On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

5.	The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 1 mg/kg.

26.10.2030

(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

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