Commission Implementing Regulation (EU) 2021/658 of 21 April 2021 concerning the authorisation of essential oil from Origanum vulgare L. subsp. hirtum (Link) letsw. Var. Vulkan (DOS 00001) as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/658
• Articles: 3

Article 1 Authorisation

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

Article 2 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 .

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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b317eo

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Essential oil from Origanum vulgare L., subsp. hirtum , (Link) letsw. Var. Vulkan (DOS 00001)

Additive composition

Essential oil from Origanum vulgare L. subsp. hirtum ( Link) letsw. Var. Vulkan (DOS 00001).

Characterisation of the active substance

Essential oil as defined by the Council of Europe  ( 1 )

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60-65 % carvacrol;

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1-3 % thymol

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4-9 % γ-terpinene

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5-10 % p-cymene

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< 5 % linalool

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2-5 % ß caryophyllene

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< 1,5 % α-terpinene

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< 2 % terpinen-4-ol

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0,3-1,0 % trans sabinene hydrate

CoE No: 317

CAS number: 336185-21-8

FEMA: 2660

Method of analysis

( 2 )

For the identification of the major constituents and for the quantification of the phytochemical marker (carvacrol) in the feed additive:

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gas chromatography coupled to mass spectrometry and flame ionisation detection (GC-MS and GC-FID)

For the determination of Oregano essential oil in premixtures:

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water-steam distillation combined with gas chromatography coupled to mass spectrometry and flame ionisation detection (GC-MS and

GC-FID)

All animal species

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150

1.

The additive shall be incorporated into feed in the form of a premixture.

2.

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

3.

The mixture of Essential oil from Origanum vulgare L. subsp. hirtum (Link) letsw. Var. Vulkan (DOS 00001) with other authorised additives obtained from Origanum vulgare L. shall not be allowed in feedingstuffs.

4.

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.

12 May 2031

( 1 )   Natural sources of flavourings – Report No 2 (2007).

( 2 )   Details of the methods of analysis are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports