Ferric Sodium EDTA

July 2006: Application from AKZO Nobel Functional Chemical to approve ferric sodium EDTA as a novel food ingredient. Authorised June 2010

Background

The applicant originally proposed to market ferric sodium EDTA as a source of iron for use in the manufacture of foods for particular nutritional uses and food supplements as a direct replacement for permitted forms of iron within the EU. The applicant has now extended their request to include fortified foods and has provided an updated dossier. Approval is sought under Novel Foods Regulation (EC) No 258/97.

Legal Backgroud

Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).

One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.

Application Status: Authorised

Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is normally carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP).   

In this case the UK notes that the use of the ingredient in these products requires assessment and authorisation under Council Directives 89/398/EEC, 2002/46/EC and Regulation (EC) 1925/2006, we have therefore concluded that the novel food application requires additional assessment, as foreseen in article 6(3) of Regulation 258/97, and that a decision on authorisation as a novel food ingredient should be taken once EFSA's advice is available. 

Following the EFSA opinion on this ingredient published in November 2009, AKZO Nobel Functional Chemical was granted authorisation in June 2010 to market ferric sodium edta in the EU by Commission Decision 2010/331/EU.