
Article 1 
Ferric Sodium EDTA as a source of iron as specified in the Annex I may be placed on the market in the Union as a novel food ingredient to be used in food without prejudice to the specific provisions of Regulation (EC) No 953/2009, Directive 2002/46/EC and/or Regulation (EC) No 1925/2006.
The maximum amount of Ferric Sodium EDTA (expressed as anhydrous EDTA) to be used in foods is set out in Annex II.
Article 2 
The designation of the novel food ingredient authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Ferric Sodium EDTA’.
Article 3 
This Decision is addressed to Akzo Nobel Chemicals GmbH, Kreuzauer Strasse 46, D — 52355 Düren.
Done at Brussels, 14 June 2010.
For the Commission
John DALLI
Member of the Commission
ANNEX I
Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odourless free-flowing, yellow to brown powder with a chemical purity of more than 99 % (w/w). It is freely soluble in water.

CAS No18154-32-0 (CAS anhydrous 15708-41-5)Chemical FormulaC10H12FeN2NaO8 * 3H2OStructural Formula


Chemical characteristics of Ferric Sodium EDTA without prejudice to the provisions of Regulation (EC) No 953/2009, Directive 2002/46/EC and/or Regulation (EC) No 1925/2006
pH of 1 % solution 3,5 to 5,5
Iron 12,5 % to 13,5 %
Sodium 5,5 %
Water 12,8 %
Organic matter (CHNO) 68,4 %
EDTA 65,5 % to 70,5 %
Water insoluble matter not more than 0,1 %
Nitrilo-triacetic acid not more than 0,1 %

ANNEX II
Food supplements (in accordance with Directive 2002/46/EC) children: 18 mg per daily dose as recommended by the manufacturer
adults: 75 mg per daily dose as recommended by the manufacturer
Dietetic foods (in accordance with Regulation (EC) No 953/2009) 12 mg EDTA per 100 g of final food
Fortified foods (in accordance with Regulation (EC) No 1925/2006) 12 mg EDTA per 100 g of final food