Preparation of eugenol, cinnamaldehyde and capsicum oleoresin

In the current application an authorisation is sought under Article 4(1) for a preparation of eugenol, cinnamaldehyde and capsicum oleoresin, under the category/functional group 4(c) “zootechnical additives”/“substances which favourably affect the environment” according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for dairy cows and cows for reproduction. According to the Applicant, the feed additive is a preparation consisting of the following active substances (expressed as percentage mass fractions related to the feed additive): 8.5 to 10.5 % of eugenol, 4.9 to 6.1 % of cinnamaldehyde and 3.1 to 3.9 % of capsicum oleoresin. The feed additive is intended to be added directly into compound feed or through premixtures (or mineral feed). The Applicant proposed the dose of 100 mg feed additive / kg compound feed. For the determination of eugenol, cinnamaldehyde and capsicum oleoresin (as the sum of capsaicin and dihydrocapsaicin) in the feed additive, the Applicant submitted a single-laboratory validated and further verified multi-analyte method based on gas chromatography coupled to flame ionisation detection (GC-FID). Based on the performance characteristics available, the EURL recommends for the official control the single-laboratory validated and further verified multi-analyte GC-FID method for the determination of eugenol, cinnamaldehyde and capsicum oleoresin in the feed additive. As the accurate determination of the content of the preparation of eugenol, cinnamaldehyde and capsicum oleoresin added to premixtures and compound feed is not achievable experimentally, the EURL cannot evaluate or recommend any method for official control to determine the content of the preparation of eugenol, cinnamaldehyde and capsicum oleoresin in premixtures and compound feed. However, the EURL considers that the single-laboratory validated and further verified methods based on gas chromatography-mass spectrometry (GC-MS) submitted by the Applicant are fit-for-purpose for the determination of eugenol in premixtures, mineral feed and compound feed at the levels investigated in the frame of the validation and verification studies. 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.