EFSA publishes data requirements for food additive approval

By Lorraine Heller

- Last updated on GMT

Related tags: Food additives, European union

The European Food Safety Authority (EFSA) has published a list of data requirements that industry must submit for the assessment of food additives.

These requirements will form part of new regulations adopted by the European Commission in December, which will replace previous directives concerning permitted food additives.

Specifically, Regulation (EC) No 1331/2008 lays out criteria that food additives, food enzymes and food flavourings must fulfill in order to be approved. The data requirements published yesterday by EFSA’s ANS panel (panel on additives and nutrient sources added to food) will be considered by the Commission when finalising legislative measures relating to the evaluation and authorisation of food additives.

The aim of this regulation is to set up a consistent process, which will involve a safety evaluation by EFSA, followed by final approval by the Commission.

EFSA’s Scientific Committee on Food adopted the guidance document for food additive evaluations in 2001, and this was provisionally endorsed by the ANS Panel last year. The panel plans to start a “detailed reappraisal”​ of the guidance next month, and expects that the guidance will be finalised in July 2011 after a period of public consultation.

Data requirements

Dossiers for the evaluation of food additives should include information on:

  • The applicant and the application dossier (administrative data)
  • The identity and characterisation of the additive (including the proposed specifications and analytical method)
  • The manufacturing process
  • The stability, reaction and fate in foods to which the additive is added
  • The case of need and proposed uses

Data that must be included in dossiers to enable a safety assessment should include:

  • All available data relevant for the purpose of risk assessment
  • Documentation specifying how the data in the dossier was gathered
  • A description of the safety evaluation strategy
  • Raw data on unpublished studies should also be available on request

In terms of biological and toxicological data, EFSA requires the following areas to be covered:

  • Toxicokinetics
  • Subchronic toxicity
  • Genotoxicity
  • Chronic toxicity/carcinogenicity
  • Reproductive and developmental toxicity

The industry association Confederation of the Food and Drink Industries of the EU told FoodNavigator.com it agrees​it is “important that assessment procedures are clear right from the beginning of an approval procedure, as we have seen in many cases.”

To access the full opinion, click here​.

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