3-Nitrooxypropanol (preparation of minimum of 10 % of 3-nitrooxypropanol)

In the current application an authorisation is sought under Article 4 for 3-nitrooxypropanol (preparation of minimum of 10 % of 3-nitrooxypropanol) 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. Specifically, the authorisation is sought for all growing ruminants (pre-ruminating and ruminating stage).
The feed additive is a preparation containing a minimum of 10 % (w/w) of 3-nitrooxypropanol as active substance. The feed additive is intended to be incorporated in compound feed via premixtures or in raw milk and milk replacers via complementary feed formerly supplemented via premixtures. The Applicant proposed final levels of 3-nitrooxypropanol ranging from 132 to 176 mg/kg complete feedingstuffs.
For the quantification of the 3-nitrooxypropanol content in the feed additive, premixtures and compound feed the Applicant proposed a single-laboratory validated and further verified method based on reversed phase high performance liquid chromatography (RP-HPLC) coupled to spectrophotometric (UV) detection. Furthermore, in the frame of stability studies, the Applicant provided experimental data applying the proposed method in the range of use proposed. Based on the available and satisfactory performance characteristics, the EURL recommends for the official control the above mentioned single-laboratory validated and further verified RP-HPLC-UV method for the quantification of 3-nitrooxypropanol in the feed additive, premixtures and compound feed.
Moreover, the method has been further single-laboratory validated and verified for the determination of the feed additive in milk replacers. The EURL, based on the satisfactory performance characteristics presented, considers the above-mentioned RP-HPLC-UV method fit-for-purpose for the analysis of 3-nitrooxypropanol in milk replacers.
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.