Commission Implementing Regulation (EU) 2020/160 of 5 February 2020 concerning the authorisation of the preparation of oregano oil, caraway oil, carvacrol, methyl salicylate and L-menthol as a feed additive for weaned piglets (holder of authorisation Biomin GmbH) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/160
• 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 twentieth day following that of 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 additive/kg of complete feedingstuff with a moisture content of 12 %

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

4d19

Biomin GmbH

Oregano oil, caraway oil, carvacrol, methyl salicylate and L-menthol

Additive composition

Preparation of:

—

essential oils of oregano ( Origanum vulgare L.) (60-80 mg/g) and caraway seed ( Carum carvi L.) (5-10 mg/g),

—

carvacrol (60-80mg/g), methyl salicylate (10-40 mg/g) and L-menthol (30-55 mg/g)

Solid form

Weaned piglets

—

75

125

1.

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

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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 skin and eye protections.

26 February 2030

Characterisation of the active substance:

Oregano oil ( Origanum vulgare L .) (CAS number: 8007-11-2) with a content of linalool of 1,8-16 mg/g;

Caraway seed oil ( Carum carvi L.) (CAS number: 8000-42-8) with a content of D-carvone of 2,5-6,5 mg/g;

Carvacrol oil (CAS number: 499-75-2) ≥ 99 % with a content of carvacrol of 95-140 mg/g (from oregano and pure carvacrol);

Methyl salicylate (CAS number: 119-36-8;

L-Menthol (CAS number: 2216-51-8).

Analytical method

( 1 )

Quantification of the active substances in the feed additive: gas chromatography coupled with flame ionisation detection (GC-FID).

( 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