Natural mixture of illite-illite/smectite mixed layer

In the current application an authorisation is sought under Article 4 for natural mixture of illite and illite/smectite mixed layer under the category / functional group 1(g) and 1(i) "technological additives"/"binders" and "anticaking agents", 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.
The feed additive is a naturally occurring clay composed of minimum of 35 % (w/w) of mixed layer of illite / smectite and minimum of 10 % (w/w) of illite. It also contains maximum levels of 20 % (w/w) of quartz, 15 % (w/w) of kaolinite and 5 % (w/w) of chlorite.
The feed additive is intended to be used in premixtures and compound feed. The Applicant proposed a minimum inclusion level of the feed additive of 50 g / kg compound feed.
For the characterisation of the feed additive the Applicant proposed to determine its mineralogical and elemental composition.
For the determination of the mineralogical composition of the feed additive the Applicant submitted a powder X-ray diffraction (XRD) method which is based on EN 13925 standard method. Furthermore, the feed additive was further characterised by the Applicant using X-ray fluorescence (XRF) spectrometry. This methodology is described in EN ISO 12677 standard method, which was recommended by the EURL for the characterisation of similar products in the frame of previous dossiers.
Based on the experimental evidence available, the EURL recommends for official control the crystallographic characterisation of the feed additive by X-ray diffraction (XRD) (EN 13925) together with the elemental analysis by X-ray fluorescence (XRF) (EN ISO 12677).
The Applicant provided no analytical method or experimental data for the determination of the natural mixture of illite and illite/smectite mixed layer in premixtures and compound feed, as the unambiguous determination of the feed additive added to the matrices is not achievable experimentally. Therefore, the EURL cannot evaluate nor recommend any method for official control for the determination of natural mixture of illite and illite/smectite mixed layer in premixtures and compound feed.
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.