# L_2012043EN.01001501.xml

| 16.2.2012 | EN | Official Journal of the European Union | L 43/15 |
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16.2.2012

EN

Official Journal of the European Union

L 43/15

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COMMISSION IMPLEMENTING REGULATION (EU) No 131/2012

of 15 February 2012

concerning the authorisation of a preparation of caraway oil, lemon oil with certain dried herbs and spices as a feed additive for weaned piglets (holder of authorisation Delacon Biotechnik GmbH)

(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. |
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(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.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of caraway oil, lemon oil with certain dried herbs and spices. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of caraway oil, lemon oil with certain dried herbs and spices. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of the preparation of caraway oil, lemon oil with certain dried herbs with spices, as specified in the Annex, as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of the preparation of caraway oil, lemon oil with certain dried herbs with spices, as specified in the Annex, as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 April 2011 (2) that, under the proposed conditions of use, the preparation of caraway oil, lemon oil with certain dried herbs and spices, as specified in the Annex, does not have an adverse effect on animal health, human health or the environment, and that its use can improve the growth rate of weaned piglets. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 April 2011 (2) that, under the proposed conditions of use, the preparation of caraway oil, lemon oil with certain dried herbs and spices, as specified in the Annex, does not have an adverse effect on animal health, human health or the environment, and that its use can improve the growth rate of weaned piglets. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | In order to ensure efficacy and safety and accordance with the characterisation provided by the applicant for the active substances, the maximum levels of natural substances laid down in Annex III, Part B to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (3) should be respected as regards dried herbs and spices used in the preparation, as specified in the Annex, and the product characterisations laid down in the European Pharmacopoeia should apply to caraway oil and lemon oil, respectively. |
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(5)

In order to ensure efficacy and safety and accordance with the characterisation provided by the applicant for the active substances, the maximum levels of natural substances laid down in Annex III, Part B to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (3) should be respected as regards dried herbs and spices used in the preparation, as specified in the Annex, and the product characterisations laid down in the European Pharmacopoeia should apply to caraway oil and lemon oil, respectively.

| (6) | The assessment of the preparation of caraway oil, lemon oil and dried herbs with spices, as specified in the Annex, shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation. |
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(6)

The assessment of the preparation of caraway oil, lemon oil and dried herbs with spices, as specified in the Annex, shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2012.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  EFSA Journal 2011; 9(4):2139.

2

EFSA Journal

(3)  
  OJ L 354, 31.12.2008, p. 34.

3

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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 |
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| mg of the additive/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) |
| 4d6 | Delacon Biotechnik GmbH | Preparation of caraway oil, lemon oil with dried herbs and spices | | Additive composition

  Preparation of essential oil > 1,5 % (caraway oil ≥ 0,75 % and lemon oil ≥ 0,75 %)






  — | Dried herbs and spices: 50 % |

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 the additive/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d6

Delacon Biotechnik GmbH

Preparation of caraway oil, lemon oil with dried herbs and spices

Additive composition

Preparation of essential oil > 1,5 % (caraway oil ≥ 0,75 % and lemon oil ≥ 0,75 %)

—

Dried herbs and spices: 50 %

| — | Carriers substances: q.s. 100 % |
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—

Carriers substances: q.s. 100 %

| | Characterisation of the active substances and other ingredients







  — | caraway oil: d-carvone 3,5-6,0 mg/g, as defined by the European Pharmacopoeia (1) |
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Characterisation of the active substances and other ingredients

—

caraway oil: d-carvone 3,5-6,0 mg/g, as defined by the European Pharmacopoeia (1)

| — | lemon oil: limonene 2,3-9,0 mg/g, as defined by the European Pharmacopoeia |
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—

lemon oil: limonene 2,3-9,0 mg/g, as defined by the European Pharmacopoeia

Dried herbs and spices:

Clove powder 1,5 %, cinnamon powder 10 %, nutmeg powder 1,5 %, onion powder 5 %, pimento powder 2 %, orange peel powder 5 %, peppermint power 12,5 % and chamomile powder 12,5 %.

The maximum levels laid down in Part B of Annex III to Regulation (EC) No 1334/2008 shall be respected as regards dried herbs and spices used in the preparation.

The product characterisations laid down in the European Pharmacopoeia shall apply to caraway oil and lemon oil used in the preparation.

| | Method of analysis
   (2)

  Determination of carvone: gas-chromatographic/mass-spectrometry (GC/MS) in single ion monitoring (SIM). |
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Method of analysis
   (2)

Determination of carvone: gas-chromatographic/mass-spectrometry (GC/MS) in single ion monitoring (SIM).

Piglets (weaned)

—

250

400

| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |
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1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | For use in weaned piglets up to approximately 35 kg. |
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2.

For use in weaned piglets up to approximately 35 kg.

| 3. | For safety: breathing protection and gloves shall be used during handling. |
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3.

For safety: breathing protection and gloves shall be used during handling.

| 4. | The additive shall be incorporated in compound feedingstuff in form of a premixture. |
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4.

The additive shall be incorporated in compound feedingstuff in form of a premixture.

7 March 2022

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(1)  European Pharmacopoeia of the Council of Europe.

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

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