Iron sodium tartrates (1i534)

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2016/896

Quantification of meso-tartrate and D(-), L(+)-tartrates in the feed additive:

— High Performance Liquid Chromatography with Refraction Index detection (HPLC-RI)

Quantification of total iron in the feed additive:

— Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN 15510, or

— Inductively Coupled Plasma Atomic Emission Spectroscopy after pressure digestion (ICP-AES) — EN 15621, or

— Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN ISO 11885, or

— Atomic Absorption Spectrometry (AAS) — EN ISO 6869, or

— Atomic Absorption Spectrometry (AAS) — Commission Regulation (EC) No 152/2009

Quantification of total sodium in the feed additive:

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

— Inductively Coupled Plasma Atomic Emission Spectroscopy after pressure digestion (ICP-AES) — EN 15621; or

— Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN ISO 11885; or

— Atomic Absorption Spectrometry (AAS) — EN ISO 6869

Quantification of total chloride in the feed additive:

— Titrimetry — Commission Regulation (EC) No 152/2009 or ISO 6495

Executive Summary

In the current application authorisation is sought under article 4(1) for Complexation products of sodium tartrates with iron (III) chloride under the category/functional group 1(i) ‘technological additives’/‘anticaking agents’ according to the classification system of Regulation (EC) No 1831/2003. Specifically, authorisation is sought for the use of the feed additive for all animal species and categories.

The feed additive is a dark green aqueous solution consisting of ca. 35 % (w/w) of complexation products of sodium tartrates with iron (III) chloride in water. For the dry product the Applicant specified minimum levels for meso-tartrate (37 %), D- & L-tartrates (14 % ) and iron (8 %); and maximum levels for chloride (25 % ) and sodium (23 %) - all values expressed in % w/w.

According to the Applicant, the feed additive is intended to be sprayed directly on sodium chloride salt to obtain a maximum content of 12 mg iron / kg salt. The product as such is not meant to be included directly in premixtures or feedingstuffs, but only via the mixture of the product in the salt.

For the quantification of meso-tartrate and D(-), L(+)-tartrates in the feed additive, the Applicant submitted a multi-analyte single laboratory validated and further verified method based on high performance liquid chromatography with refractive index detection (HPLC-RI). The following performance characteristics were reported in the frame of the validation and verification studies: - a relative standard deviation for repeatability (RSD_r) ranging from 0.1 to 2.1 %; and - a relative standard deviation for intermediate precision (RSD_ip) ranging from 1.1 to 5.8 %.

For the quantification of chloride, iron or sodium total contents in the feed additive the EURL identified several internationally recognised methods:

two Community methods based on titrimetry (for chloride), and on Atomic Absorption Spectrometry (AAS) (for total iron); several ISO and CEN ring-trial validated methods: ISO 6495 based on titrimetry (for chloride); EN 15510, EN 15621 and EN ISO 11885, based on Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES), and EN ISO 6869, based on AAS (for iron and sodium).

For the quantification of water content in the feed additive the Applicant suggested the loss on drying method described in the generic European Pharmacopoeia monograph (Ph. Eur. 20232).

Based on the experimental evidence available the EURL recommends for official control all the methods mentioned above to characterise the feed additive.

The Applicant provided no experimental data or any analytical method for the quantification of the active substances in premixtures and feedingstuffs as the feed additive is not to be added directly to premixtures and 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.