Great mullein tincture - 2b475(m)-t

In the current application authorisation is sought under Article 4(1) for the botanically defined great mullein tincture under the category/functional group (2 b) "sensory additives"/"flavouring compounds", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the feed additive is sought to be used for all animal species and categories. 

The feed additive is a mixture of naturally occurring chemical components, including total polyphenols and total phenolic acids as major constituents. The feed additive is intended to be incorporated directly into feedingstuffs alone or in combination with other flavouring substances (flavouring premixtures). The Applicant did not propose any minimum or maximum content of great mullein tincture in feedingstuffs. 

The Applicant did not indicate any phytochemical marker and did not provide any corresponding method, but other methods aiming at the identification/characterisation of the feed additive. 

The Applicant characterised the feed additive by determination of: loss on drying and ash content (gravimetry); total polyphenols (spectrophotometry); and total phenolic acids (high performance thin layer chromatography - HPTLC). 

Furthermore, the Applicant has provided as reference a typical HPTLC profile of great mullein tincture's phenolic acids with the aim to provide a tool for the unambiguous identification of the feed additive. A detailed description of the characteristics of the profile has been included. 

For the identification/characterisation of the feed additive the EURL considers the methods based on gravimetry, spectrophotometry and high performance thin layer chromatography (HPTLC) proposed by the Applicant as fit-for-purpose. 

Furthermore, the Applicant did not provide experimental data or analytical method for the determination of great mullein tincture in premixtures and feedingstuffs as the unambiguous determination of the feed additive added to the matrices is not achievable experimentally. 

Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.

Recommended Method

as of:

Commission Implementing Regulation (EU) 2022/702 

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