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Selenised yeast Saccharomyces cerevisiae Y03-0 inactivated

Selenium

Details

Publication date
14 January 2022 (Last updated on: 26 January 2022)

Description

Executive Summary

In the current application an authorisation is sought under Article 4(1) for selenised yeast Saccharomyces cerevisiae Y03-0 inactivated under the category/ functional group (3b) "nutritional additives"/"compounds of trace elements", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for the use of the feed additive for all animal species.
According to the Applicant, the feed additive is intended to be marketed as two solid granulated or micro-granulated preparations containing a minimum of 3000 mg of total selenium / kg of the preparation. Each preparation contains a minimum of 98 % (w/w) of organic selenium and at least of 63 % (w/w) of total selenium in each preparation is in the form of selenomethionine.
The feed additive is intended to be incorporated into feedingstuffs through premixtures at a proposed maximum dose of 0.50 mg total selenium / kg of complete feedingstuffs. The proposed levels are in agreement with several Commission Implementing Regulations, namely (EU) 2020/2117, (EU) 2019/804, (EU) 2015/489 and (EU) No 427/2013 for total selenium content from selenised yeast in complete feedingstuffs.
For the quantification of selenomethionine in the feed additive the Applicant proposed the single-laboratory validated and verified method based on high performance liquid chromatography and inductively coupled plasma-mass spectrometry (HPLC-ICP-MS) after triple proteolytic digestion. This method has been previously evaluated and recommended by the EURL in the frame of FAD-2009-0010 for the quantification of selenomethionine in selenium enriched yeast. In addition, the EURL identified another single-laboratory validated and verified method based on reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV), which has been also evaluated and recommended for the quantification of selenomethionine in the product in the frame of the above mentioned dossier. Furthermore, the two above mentioned methods were further included in Commission Implementing Regulation (EU) 2015/489 authorising the product of FAD-2009-0010. In addition, these two methods were also included in the Commission Implementing Regulations (EU) 2020/2117 and (EU) 2019/804 authorising other similar selenised yeast products.
Based on the overall available data, the EURL considers the two mentioned methods based on HPLC-ICP-MS and HPLC-UV also suitable for official control for the quantification of selenomethionne in the feed additive of the current application.
For the quantification of total selenium in the feed additive the Applicant proposed the EN 17053 based on inductively coupled plasma-mass spectrometry (ICP-MS). This method was tested for feed samples in the ring-trial validation studies for total selenium content ranging from 0.4 to 13.3 mg / kg feed. However, the Applicant did not submit any data demonstrating the applicability of the method for the product of the current application with much higher content of selenium (ca. 3000 mg / kg).
Meanwhile, the EURL identified two single-laboratory validated and verified methods based on inductively coupled plasma-atomic emission spectrometry (ICP-AES) and ICP-MS, which have been previously evaluated and recommended for official control in the frame of several dossiers for similar products of selenised yeast and further included in several Commission Implementing Regulations authorising the selenised yeast products.
Based on the overall available data, the EURL considers the two mentioned methods based on ICP-AES and ICP-MS also suitable for official control for the quantification of total selenium in the feed additive of the current application.
For the quantification of total selenium in premixtures and feedingstuffs the Applicant proposed the EN 16159 method based on hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion with 65 % nitric acid and 30 % hydrogen peroxide.
The following performance characteristics are reported in the frame of ring-trial validation studies for the determination of total selenium content in feedingstuffs ranging from 0.25 to 73.6 mg / kg: a relative standard deviation for repeatability (RSDr) ranging from 3.4 to 10.1 %; a relative standard deviation for reproducibility (RSDR) ranging from 14.9 to 23.2 %; and a limit of quantification of 0.125 mg / kg feedingstuffs.
This method has been previously evaluated and recommended by the EURL for official control of total selenium content in premixtures and feedingstuffs in the frame of several dossiers for similar selenised yeast products. The method was further included in several Commission Implementing Regulations authorising the selenised yeast products.
Based on the overall available data, the EURL considers the EN 16159 method also suitable for official control for the quantification of total selenium in premixtures and feedingstuffs in the frame of the current application.
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.

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finrep-fad-2021-0045-selenised-yeast.pdf
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