Leaves extract of Melissa officinalis L. - 2b280-ex

In the current application authorisation is sought under articles 4(1) and 10(2) for Melissa officinalis dry extract 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. Melissa officinalis dry extract, also known as lemon balm extract, is an extract from leaves of Melissa officinalis L. It contains 3 to 6% rosmarinic acid, used as a phytochemical marker to trace the active substance. Specifically, authorisation is sought for the use of Melissa officinalis dry extract for all animal species and categories. It is intended to be incorporated in complete feedingstuffs or in drinking water at a dose ranging from 2.5 to 100 mg/kg.

For the identification and determination of Melissa officinalis dry extract in the feed additive, the Applicant proposed the internationally recognised European Pharmacopoeia method, based on High Performance Liquid Chromatography (HPLC) coupled to ultraviolet detection. The method is based on the determination of rosmarinic acid (phytochemical marker of Melissa officinalis dry extract), using reference solution of rosmarinic acid. Even though no performance characteristics are provided, the EURL recommends for official control the European Pharmacopoeia method – Ph. Eur. 6.0, method 01/2010:2524, for the qualitative identification of Melissa officinalis dry extract in the feed additive.

The Applicant did not provide any experimental method or data for the determination of Melissa officinalis dry extract in premixtures, feedingstuffs and water. Furthermore, the unambiguous determination of the content of Melissa officinalis dry extract added to premixtures and feedingstuffs is not achievable by analysis. Therefore, the EURL cannot evaluate nor recommend any method for official control to determine Melissa officinalis dry extract in premixtures, feedingstuffs and water. 

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) is not considered necessary.

Recommended Method

as of:

Commission Implementing Regulation (EU) 2022/653

For the quantification of rosmarinic acid (phytochemical marker) in the feed additive (Melissa officinalis L. dry extract):

reversed phase high performance liquid chromatography coupled to spectrophotometric detection (HPLC-UV) (European Pharmacopoeia monograph 2524)