Copper(I) oxide (3b412)

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2016/2261

For the identification of Cu2O in the additive:

- X-Ray diffraction (XRD)

For the quantification of the total copper content in the additive:

- Titrimetry;

or

- Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN 15510

For the quantification of total copper content in premixtures:

- Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN 15510; or

- Inductively Coupled Plasma Atomic Emission Spectrometry after pressure digestion (ICP-AES) - EN 15621

For the quantification of total copper content in feed materials and compound feed:

-Atomic Absorption Spectrometry (AAS) - Commission Regulation (EC) No 152/2009; or

- Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN 15510; or

- Inductively Coupled Plasma Atomic Emission Spectrometry after pressure digestion (ICP-AES) - EN 15621

Executive Summary

In the current application authorisation is sought under article 4(1) for Dicopper oxide 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, authorisation is sought for the use of the feed additive for all categories and species. The Applicant intends to market a red-brown granulated formulation (CoRouge®) containing ca. 86 % of dicopper oxide (feed additive) - equivalent to a total copper content ranging from 73 to 77 % - together with ca. 13% of lignosulphonate and 1% of bentonite. The feed additive is intended to be incorporated into feedingstuffs through premixtures. The Applicant suggested maximum levels of total copper in the feedingstuffs complying with the limits set in Regulations (EC) No 1334/2003 and ranging from 15 to 170 mg/kg, depending of the animal species/category.

For characterisation of dicopper oxide (Cu2O) the Applicant submitted an X-ray diffraction method (XRD), described in the generic European Pharmacopoeia monograph (Eur. Ph. 6.0, 01/2008:20933), to identify the crystalline structure of Cu2O together with a single-laboratory validated titrimetric method for the quantification of total copper in Cu2O. The validity of the titration method was demonstrated for the product (CoRouge®) and the titration results were further confirmed by the analyses of the product performed by ICP-AES according to the protocol described in the EN 15510 standard, mentioned below.

For the quantification of total copper in premixtures and feedingstuffs the Applicant submitted the internationally recognised ring-trial validated EN 15510 method based on inductively coupled plasma atomic emission spectroscopy (ICP-AES) after ashing and/or treatment with hydrochloric acid. In the meantime, the EURL already evaluated in the frame of the Copper group dossiers (FAD-2010-0031; FAD-2010-0070; FAD-2010-0331) an alternative ring-trial validated EN 15621 method, based on ICP-AES after pressure digestion. Furthermore, a Community method is available for the quantification of total copper in feedingstuffs, which was further ring-trial validated by the UK Food Standards Agency.

Based on the available information the EURL recommends for official control the X-Ray diffraction and the titrimetric method submitted by the Applicant for the characterisation of dicopper oxide (feed additive), together with the two CEN (EN 15510 or EN 15621) and Community (Com Reg (EC) No 152/2009 – Annex IV-C) methods for the quantification of total copper in the feed additive, premixtures and/or feedingstuffs.

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) is not considered necessary.