Food Additives

Food additives are substances added intentionally to foodstuffs to perform certain technological functions, for example to colour, to sweeten or to help preserve foods.

In the European Union all food additives are identified by an E number. Food additives are always included in the ingredient lists of foods in which they are used. Product labels must identify both the function of the additive in the finished food (e.g. colour, preservative) and the specific substance used either by referring to the appropriate E number or its name (e.g. E 415 or Xanthan gum). The most common additives to appear on food labels are antioxidants (to prevent deterioration caused by oxidation), colours, emulsifiers, stabilisers, gelling agents and thickeners, preservatives and sweeteners.

Topics: Completed work

EFSA’s expert Panel on Food Additives and Nutrient Sources Added to Food (ANS) carries out its safety evaluations of food additives. It reviews all available, relevant scientific data, including information on chemical and biological properties, potential toxicity and estimates of human dietary exposure. Based on these data, the Panel draws conclusions on the safety of the intended uses of the food additive for the consumers.

The ANS Panel assesses the safety of new food additives and new uses of permitted food additives. Since 2009 the Panel has also been re-evaluating all then permitted food additives, completion of which is due by 2020.

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2016 Completed the last two re-evaluations of food colours completing this major programme. Overall, the ANS Panel re-assessed 41 food colours.

2014 Panel adopted a statement on the conceptual framework for its risk assessments of certain food additives included in the re-evaluation programme.

2013 Re-evaluation of the sweetener aspartame brought forward and completed following request from European Commission.

2013 update of EFSA’s ‘Food additives intake model’ (FAIM) template. This is an exposure assessment tool specifically developed by EFSA to support the calculation by applicants of estimates of exposure to the food additive and its by-products. Use of the tool is also intended to harmonise the submission of the related data.

2012 The ANS Panel adopted guidance for the submission of food additive applications, reflecting advances in science and the latest risk assessment principles. It replaced guidance from 2001 by the European Commission’s former Scientific Committee on Food (SCF) and later endorsed by EFSA’s Panels for use in their risk assessments.

2009 In line with Regulation EC 1331/2008, the ANS Panel specified the type of data that industry should provide for the safety assessment of food additives.

2008 EFSA established the Panel on Food Additives and Nutrient Sources Added to Food (ANS)

EFSA has three main tasks in relation to food additives:

  • Evaluating the safety of new food additives or proposed new uses of existing food additives before they can be authorised for use in the EU
  • Re-evaluating all food additives already permitted for use in the EU before 20 January 2009
  • Responding to ad-hoc requests from the European Commission to review certain food additives in the light of new scientific information and/or changing conditions of use.

Setting the “safe level”

As part of its safety evaluations of food additives EFSA seeks to establish, when possible (e.g. when sufficient information is available), an Acceptable Daily Intake (ADI) for each substance.

The ADI is the amount of a substance that people can consume on a daily basis during their whole life without any appreciable health risk. ADIs are usually expressed in mg per kg of body weight per day (mg/kg bw/day). The ADI can apply to a specific additive or a group of additives with similar properties. When re-evaluating previously authorised additives, EFSA may either confirm or amend an existing ADI following review of all available evidence.

When there are insufficient data for establishing an ADI, a margin of safety may be calculated to determine whether estimated exposure might be of potential concern.

In other cases, for example, for substances that are already present in the body or regular components of the diet or that did not indicate adverse effects in animal studies, there is no need to set an ADI.

Under EU legislation, food additives must be authorised before they can be used in foods.

The authorisation procedure starts with submission of a formal request to the European Commission consisting of an application dossier on the substance, containing scientific data on its proposed uses and use levels. The Commission then sends the dossier to EFSA and requests it to evaluate the safety of the substance for its intended uses. The European Commission decides whether to authorise the substance based on EFSA’s safety assessment. Authorisation of proposed new uses of existing food additives follows the same procedure.

Once authorised, these substances are included in the EU list of permitted food additives laid down in Regulation EC 1333/2008, which also specifies their conditions of use. Authorised food additives must also comply with approved purity criteria laid down in Regulation EU 231/2012.

In December 2008, existing legislation was consolidated into four simplified regulations covering all so-called food improvement agents (i.e. food additives, food enzymes and flavourings). Regulation EC 1331/2008 introduced a common authorisation procedure for these agents. Regulation EC 1333/2008 on food additives established a Union list of authorised food additives, which was published in full in Regulation EU 1129/2011.