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2010/331/: Commission Decision of 14 June 2010 authorising the placing on the market of Ferric Sodium EDTA as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2010) 3729)

2010/331/: Commission Decision of 14 June 2010 authorising the placing on the market of Ferric Sodium EDTA as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2010) 3729)

Regulation (EC) No 258/97 · Decision · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

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.

Supplementary provisions

ANNEX ISupplementary provisions

ANNEX I Specifications of Ferric Sodium EDTA DESCRIPTION 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 No : 18154-32-0 (CAS anhydrous 15708-41-5) Chemical Formula : C 10 H 12 FeN 2 NaO 8  * 3H 2 O Structural 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 IISupplementary provisions

ANNEX II Maximum amounts of Ferric Sodium EDTA (expressed as anhydrous EDTA) 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

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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