Mugwort tincture - 2b72-t

In the current application authorisation is sought under Article 4(1) for the botanically defined Mugwort 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 additiveis a mixture of naturally occurring chemical components including total polyphenols, total phenolic acids, chlorogenic acid, alpha- and beta- thujones and eucalyptol as the major constituents, and it is intended to be incorporated directly into feedingstuffs or through flavouring premixtures without minimum or maximum limits.

The Applicant did not provide a method for the determination of the phytochemical marker, but submitted other methods aiming at the identification/characterisation of the feed additive (Mugwort tincture). 

The Applicant proposed to characterise the feed additive (Mugwort tincture) by determination of loss on drying, ash content (measured by gravimetry), total polyphenols (measured by spectrophotometry), total phenolic acids, chlorogenic acid, alpha- and beta- thujones and eucalyptol (measured by high performance thin layer chromatography (HPTLC)). According to the Applicant, the use of the HPTLC profiles as a fingerprint of the feed additive is more reliable than the analysis of individual phytomarkers at an established range.

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 Mugwort 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) 2021/421

- Commission Implementing Regulation (EU) 2022/385

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