Dry Grape Extract

Executive Summary

In the current application an authorisation is sought under Article 4 for Dry Grape Extract under the category / functional group (4 e) "zootechnical additives" / "physiological condition stabilisers", 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 poultry species.
The feed additive (Dry Grape Extract) is a dry grape extract of Vitis vinifera spp. Vinifera with a minimum contents of 80 % (w/w) of polyphenols (active substance) and 0.7 g / kg of malvidin-3-O-glucoside (phytochemical marker), respectively. The feed additive is intended to be incorporated directly into feedingstuffs or through premixtures at a recommended minimum and maximum content of Dry Grape Extract (feed additive) of 30 and 100 mg / kg feedingstuffs, respectively. This feed additive is currently authorised as sensory additive by Commission Implementing Regulation (EU) No 2017/307.
For the determination of the total polyphenols (active substance) content in Dry Grape Extract (feed additive), the Applicant submitted a method based on spectrophotometry at 280 nm using external calibration with catechin standards. This method has been single-laboratory validated and further ring-trial validated leading to relative standard deviation for reproducibility (RSDR) ranging from 1.2 to 4.5 %, and recovery rates (Rrec) up to 130 %.
Based on the acceptable performance characteristics the EURL recommends for official control the above-mentioned method based on spectrophotometry for the determination of the total polyphenols in the feed additive (Dry Grape Extract).
The Applicant did not provide any experimental data or an analytical method for the determination of the total polyphenols in premixtures and feedingstuffs.
The Applicant also proposed three chromatographic methods for the determination of malvidin-3-O-glucoside (phytochemical marker) in the feed additive, premixtures and feedingstuffs.
Based on the acceptable performance characteristics presented, the EURL considers the proposed chromatographic methods suitable for official control for the determination of malvidin-3-O-glucoside (phytochemical marker) in the feed additive, premixtures and feedingstuffs.
Moreover, as the unambiguous determination of the feed additive (Dry Grape Extract) added to premixtures and feedingstuffs is not achievable experimentally, the EURL cannot evaluate nor recommend any method for official control for the determination of Dry Grape Extract in premixtures and feedingstuffs.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.