Capsaicin

In the current application an authorisation is sought under Article 4(1) for capsaicin 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. The authorisation is sought for the use of the feed additive for all animal species.
According to the Applicant the product contains as active substance capsaicin with a minimum content of 98 % (w/w) feed additive. The active substance is present in the product with the two isomers i.e. trans-capsaicin and cis-capsaicin in a ratio of ≥ 6:1. Capsaicin is intended to be mixed into feed via premixtures. The Applicant did not propose a minimum or a maximum level of the feed additive but suggested a maximum content of the active substance of 6.5 mg/kg (w/w) compound feed.
For the determination of capsaicin in the feed additive the Applicant submitted a single-laboratory validated and further verified method based on reversed-phase high performance liquid chromatography (HPLC) coupled to spectrophotometric (UV) detection. The capsaicin content is determined as sum of the two-isomers (trans-capsaicin and cis-capsaicin). The following performance characteristics were provided by the Applicant in the frame of the validation and verification studies: for (i) trans-capsaicin a relative standard deviation for repeatability (RSD_r) and intermediate precision (RSD_ip) ranging respectively from 0.04 to 4.6 % and from 0.7 to 2.1 % and for (ii) cis-capsaicin a RSD_r and RSD_ip ranging respectively from 0.2 to 3.2 % and from 0.8 to 3.7 %. For the determination of capsaicin in premixtures and compound feed, the Applicant submitted two slightly different single-laboratory validated and further verified methods based on reversed-phase HPLC coupled to UV detection. The capsaicin content is determined respectively in (i) premixtures as sum of the two-isomers (trans-capsaicin and cis-capsaicin) and in (ii) compound feed as single peak quantified using external standard calibration curves. The following performance characteristics were recalculated by the EURL based on the experimental data obtained by the Applicant in the frame of the validation and verification studies: for (i) premixtures a RSD_r and RSD_ip ranging respectively from 0.30 to 0.50 % and from 0.37 to 0.97 % and for (ii) compound feed a RSD_r and RSD_ip ranging from 0.95 to 2.47 %.
Based on the performance characteristics available, the EURL recommends for official control the single-laboratory validated and further verified methods based on reversed-phase HPLC-UV detection for the quantification of capsaicin in the feed additive, premixtures and compound feed. 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.