Phenylcapsaicin

In the current application an authorisation is sought under Article 4 for phenylcapsaicin under the category/functional group 4(e) "zootechnical additives"/"Physiological condition stabilisers", according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for chickens for fattening.
According to the Applicant, the product contains as active substance not less than 98 % (w/w) phenylcapsaicin. The product is intended to be incorporated directly into compound feed at a level ranging from 10 to 15 mg / kg complete feed.
For the determination of phenylcapsaicin in the feed additive the Applicant proposed a single-laboratory validated and further verified method based on reversed-phase high performance liquid chromatography (HPLC) coupled to spectrophotometric (UV) detection. Based on the presented performance characteristics, the EURL recommends for official control the single-laboratory validated and further verified method based on HPLC coupled to UV detection for the determination of phenylcapsaicin in the feed additive.
For the determination of phenylcapsaicin in compound feed the Applicant proposed an analytical method based on HPLC coupled to UV detection (HPLC-UV). The analytical method was not supported by any validation and / or verification study and could not be considered fit for purpose for official control. However, in the frame of the current dossier, a second single-laboratory validated and further verified method based on liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) has been presented for the “determination of phenylcapsaicin in liquid and solid feed”. The following performance characteristics are reported: a relative standard deviation for repeatability (RSDr) ranging from 1.1 to 7.2 %, a relative standard deviation for intermediate precision (RSDip) of 1.9 % and a recovery rate (RRec) ranging from 77 to 107 %. Furthermore, the Applicant reported a limit of detection (LOD) and a limit of quantification (LOQ) respectively of 0.03 and 0.1 mg / kg compound feed. Based on the performance characteristics, the EURL recommends for official control the single-laboratory validated and further verified method based on liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) for the determination of phenylcapsaicin in compound feed.
The Applicant presented a single-laboratory validated and further verified method based on LC-MS/MS for the determination of phenylcapsaicin residues in animal tissues is provided. The following performance characteristics are reported for the analysis in liver in a range between 2x10-4 to 0.02 mg / kg: a RSDr ranging from 0.1 to 4.4 %, a RSDip of 3.8 % and a RRec ranging from 100 to 119 %. Furthermore, the Applicant reported a LOQ of 2x10-4 mg/kg. However, the Applicant did not propose any maximum residue levels (MRL) of phenylcapsaicin in tissues of chicken for fattening. Therefore, the EURL cannot evaluate the fitness for purpose of this analytical method.
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.