Commission Regulation (EU) 2024/346 of 22 January 2024 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of trimagnesium dicitrate in food supplements

• CELEX: Regulation (EU) 2024/346
• Articles: 5

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

Article 2

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

(1)

in Part B, point 3 ‘Additives other than colours and sweeteners’, the following entry is inserted after the entry for food additive E 343 Magnesium phosphates:

‘E 345(i)

Trimagnesium dicitrate’

(2)

in Part E, in food category 17.1 ‘Food supplements supplied in a solid form, excluding food supplements for infants and young children’, the following entry is inserted after the entry for E 432-436 Polysorbates:

‘E 345(i)

Trimagnesium dicitrate

100 000

(97)

(97):

In conformity with Directive 2002/46/EC’

ANNEX II

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.’