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

• CELEX: Implementing Regulation (EU) No 131/2012
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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 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 %

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

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).

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.

2.

For use in weaned piglets up to approximately 35 kg.

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.

7 March 2022

( 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