ANNEX IISupplementary provisions
ANNEX II In the Annex to Regulation (EU) No 231/2012 the following entry for E 345(i) is inserted after the entry for E 343 (ii) DIMAGNESIUM PHOSPHATE: ‘ E 345 (i) TRIMAGNESIUM DICITRATE Synonyms Magnesium citrate; trimagnesium citrate Definition Einecs 222-093-9 Chemical name Trimagnesium bis (2-hydroxypropane-1,2,3- tricarboxylate), anhydrous Chemical formula (C 6 H 5 O 7 ) 2 Mg 3 Molecular weight 451,12 (anhydrous) Assay 15,0-16,5 % Mg on dry substance/matter equal to 92,8-102,1 % trimagnesium dicitrate anhydrous Description White or almost white, fine, slightly hygroscopic powder Appearance of a solution Not more opalescent than ref. susp. III and not more intensely coloured than ref. sol. Y7 or BY6 Identification Test for citrate Positive Test for magnesium Positive pH (5 % solution) 6,0-8,5 Solubility Soluble in water, practically insoluble in ethanol (96 %), it dissolves in diluted hydrochloric acid. Particle size by STEM method – Median (D 50 ) particle size (number-based) not below 130 nm by laser diffraction method – Median (D 50 ) particle size (mass-based) not below 50 μm Purity Loss on drying Maximum 3,5 %, determined on 1 000 g by drying in an oven at 180 ± 10 °C for 5 h Oxalic/oxalate ≤ 280 mg/kg (0,028 %) as oxalic acid Sulfates ≤ 2 000 mg/kg (0,2 %) Calcium ≤ 2 000 mg/kg (0,2 %) Iron ≤ 100 mg/kg Mercury ≤ 0,1 mg/kg Lead ≤ 1 mg/kg Cadmium ≤ 0,1 mg/kg Arsenic ≤ 1 mg/kg Not identified material No process or product related impurities. The unintended presence of hydrated forms of trimagnesium dicitrate such as the nonahydrate cannot be excluded.’