Stevia extract (Stevia rebaudiana)

In the current application an authorisation is sought under Article 4 for Stevia extract (Stevia rebaudiana), under the category 2 ‘sensory additives’, functional group (b) 'flavouring compound’, according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for all animal species and categories.
The Applicant proposed total steviol glycosides as phytochemical marker with a total content ranging from 75 to 90 % (w/w) feed additive. The feed additive is intended to be mixed either into premixtures or added directly to compound feed. The Applicant proposed feed additive inclusion levels of 200 mg/kg complete feed for all animal species except chickens for fattening, turkeys for fattening and cats for which the proposed levels are 130, 180 and 105 mg/kg complete feed, respectively.
For the determination of total steviol glycosides in the feed additive the Applicant submitted the internationally recognised FAO JECFA ‘Steviol Glycosides’ monograph for food additives where an analytical method based on high performance liquid chromatography coupled with ultraviolet detection (HPLC-UV) is described for the determination of the phytochemical marker.
The Applicant, in the frame of the batch-to-batch variation studies, provided experimental data demonstrating the applicability of the HPLC-UV method for the analysis of steviol glycosides (pythochemical marker) in the feed additive.
The Applicant did not provide suitable analytical methods for the determination of steviol glycosides (pythochemical marker) in premixtures and compound feed. Therefore, the EURL cannot evaluate nor recommend any method for official control to determine the feed additive in premixtures and compound feed.
Therefore, the EURL recommends for official control the above-mentioned HPLC-UV method described in the FAO JECFA monograph for the determination of total steviol glycosides (pythochemical marker) in the feed additive. 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 and relevant amendments) is not considered necessary.