Commission Implementing Regulation (EU) 2021/421 of 9 March 2021 concerning the authorisation of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/421
• Articles: 3

Article 1

The tincture derived from Artemisia vulgaris L. (mugwort tincture) specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed 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 active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b72-t

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Mugwort tincture

Additive composition

Tincture produced from the fragmented aerial parts of Artemisia vulgaris L.

Characterisation of the active substance

Tincture produced from the fragmented aerial parts of Artemisia vulgaris L by extended extraction with a water/ethanol mixture as defined by the Council of Europe

( 1 ) .

The specifications of the active substance are:

Dry matter: 1,4-1,9 %

Ash: 0,2-0,5 %

Organic fraction: 1,13-1,65 %, of which

—

Total polyphenols:0,05-0,2 %

—

Phenolic acids 0,02-0,11 %

—

Chlorogenic acid: 0,0028-0,0136 %

—

α- and β-thujone: < 0,005 %

—

1,8-cineole:0,005 %

—

Solvent (ethanol): 98,1-98,6 %

Liquid form

CoE No 72

Analytical method

( 2 )

For the characterisation of the feed additive (Mugwort tincture):

—

gravimetric method for the determination of loss on drying and the ash content

—

spectrophotometric method for the determination of total polyphenols content

—

high performance thin layer chromatography (HPTLC) method for the determination of total phenolic acids, chlorogenic acid, alpha- and beta- thujones and eucalyptol

All animal species

-

-

1.

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

2.

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

3.

On the label of the additive and premixtures the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 400 mg/kg’

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

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.

30.3.2031

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

( 2 )   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