Camelia oleifera extract

Executive Summary

In the current application an authorisation is sought under Article 4 for a camelia oleifera extract under the category / functional group (1 c) "technological additives"/"emulsifiers", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for the feed additive to be used for all animal species (excluding fish).
The feed additive (Cosap®) is a liquid extract from tea seed meal of camelia oleifera containing a minimum content of 10.5 % (w / w) total saponins, which according to the Applicant is the active substance of Cosap®. The feed additive can be used in its liquid form or adsorbed on mineral supports or dried. Cosap® is intended to be incorporated directly into feedingstuffs or through premixtures at a recommended inclusion levels ranging from 30 to 750 mg / kg feedingstuffs.
For the determination of the total saponins content in Cosap® (the feed additive), the Applicant submitted a single-laboratory validated and further verified spectrophotometric method.
Based on the acceptable performance characteristics presented the EURL recommends for official control the single-laboratory validated and further verified spectrophotometric method for the determination of the total saponins content in the feed additive (Cosap®).
The Applicant did not provide any experimental data or an analytical method for the determination of the total saponins in premixtures and feedingstuffs.
Instead, the Applicant proposed two single-laboratory validated and further verified chromatographic methods for the determination of camelliaside A (the phytochemical marker of Cosap® as claimed by the Applicant) in premixtures and feedingstuffs.
Based on the acceptable performance characteristics presented, the EURL considers the two single-laboratory validated and further verified chromatographic methods suitable for the determination of camelliaside A in premixtures and feedingstuffs.
Moreover, as the unambiguous determination of the feed additive (Cosap®) added to premixtures and feedingstuffs is not achievable experimentally the EURL cannot recommend any method for official control for the determination of Cosap® 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.