Commission Implementing Regulation (EU) 2016/896 of 8 June 2016 concerning the authorisation of iron sodium tartrates as a feed additive for all animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2016/896@2016-06-08/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of iron sodium tartrates. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of iron sodium tartrates as a feed additive for all animal species, to be classified in the additive category technological additives.
(4) The European Food Safety Authority (the Authority) concluded in its opinion of 30 April 2015 that, under the proposed conditions of use, the preparation concerned does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparation has the potential to be efficacious as an anti-caking agent in salt. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of iron sodium tartrates shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The preparation specified in the Annex, belonging to the additive category technological additives and to the functional group anti-caking agents is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 8 June 2016. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX 1.2.3.
Identification number of the additive Additive Composition, chemical formula, description, methods of analysis Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of active substance/kg of NaCl Technological additives: anti-caking agents 1i534 Iron sodium tartrates All animals species — — — The additive shall be used only in NaCl (sodium chloride). Minimum recommended dose: 26 mg of iron sodium tartrates/kg NaCl (equivalent to 3 mg iron/kg of NaCl). Maximum recommended dose: 106 mg of iron sodium tartrates/kg NaCl. 29 June 2026
ANNEX Additive composition
Preparation of complexation products of sodium tartrates with iron(III) chloride in water solution ≤ 35 % (by weight).
Characterisation of active substance
Iron(III) complexation product of D(+)-, L(-)- and meso-2,3-dihydroxybutanedioic acids CAS number 1280193-05-9 Fe(OH)2C4H4O6Na
Ratio: iron to meso-tartrate 1:1;
Ratio: iron to total tartrate isomers 1:1,5
Chloride: ≤ 25 %
Oxalates: ≤ 1,5 % expressed as oxalic acid
Iron: ≥ 8 % iron(III)
Analytical method
Quantification of meso-tartrate and D(-), L(+)-tartrates in the feed additive: Quantification of total iron in the feed additive: Quantification of total sodium in the feed additive: Quantification of total chloride in the feed additive:
High Performance Liquid Chromatography with Refraction Index detection (HPLC-RI);
Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN 15510, or
Inductively Coupled Plasma Atomic Emission Spectroscopy after pressure digestion (ICP-AES) — EN 15621,or
Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN ISO 11885, or
Atomic Absorption Spectrometry (AAS) — EN ISO 6869, or
Atomic Absorption Spectrometry (AAS) — Commission Regulation (EC) No 152/2009; and
Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN 15510; or
Inductively Coupled Plasma Atomic Emission Spectroscopy after pressure digestion (ICP-AES) — EN 15621; or
Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN ISO 11885; or
Atomic Absorption Spectrometry (AAS) — EN ISO 6869; and
Titrimetry —Regulation (EC) No 152/2009 or ISO 6495.