Commission Implementing Regulation (EU) 2022/702 of 5 May 2022 concerning the authorisation of great mullein tincture as a feed additive for certain animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/702
• Articles: 3

Article 1

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

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 additive/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b475(m)-t

-

Great mullein tincture

Additive composition

Great mullein tincture derived from Verbascum thapsus L.

Chickens for fattening

-

50

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.

Mixture with other botanical additives is permitted provided that the amounts of aucubin in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category.

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 skin and eye protection.

26 May 2032

Liquid form

Turkeys for fattening

Characterisation of the active substance

Pigs for fattening

Great mullein tincture derived from Verbascum thapsus L. as defined by the Council of Europe  ( 1 ) .

Calves for fattening

Lambs and kids for fattening

Dry matter: ≤ 3 %

Solvent (water/ethanol):

≤ 97,5 %

Ash: ≤ 0,3 %

Aucubin: ≤ 0,006 %

Salmonids, except for reproduction purposes

Polyphenols: ≤ 0,22 %

Total flavonoids (chlorogenic acid equivalents): ≤ 0,10 %

Rabbits for fattening

Analytical method

( 2 )

For the characterisation of great mullein 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.

( 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.