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 (EU) 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 Xantham 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.

Introduction

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 (EU) 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 Xantham 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.

EFSA's role

EFSA has three main activities 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.

As part of its safety evaluations of food additives EFSA establishes, when possible (i.e. 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 risk to health. 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.

EU Framework

Under EU legislation, food additives must be authorised before they can be used in foods. Authorisation by risk managers follows a thorough safety assessment carried out by EFSA.
Once authorised, these substances are compiled on an EU list of permitted food additives, which also specifies their conditions of use. They 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.

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Under Regulation EC 1333/2008, EFSA must re-evaluate by 2020 all food additives authorised for use in the EU prior to 20 January 2009 before they can be included on the EU list. All substances authorised under previous legislation (Directives 94/35/EC on sweeteners, 94/36/EC on colours, 95/2/EC on food additives) are allowed until their review is complete.

Regulation EU 257/2010 establishes a programme for the re-evaluation of approved food additives, the details of which are in Annex II. The deadlines for the re-evaluations vary by group (see table below). The timetable may be adjusted should a safety concern arise for an individual additive and/or should new data be made available requiring further review ahead of the agreed deadline.

EU priorities for re-evaluation of certain food additives (Regulation EU 257/2010)

Deadlines Food additives
15 Apr 2010 Food colours 1: E 123, E 151, E 154, E 155, E 180
31 Dec 2010* Food colours 2: E 100, E 127, E 131, E 132, E 133, E 142, E 150a, E 150b, E 150c, E 150d, E 161b, E 161g, E 170
31 Dec 2015 Food colours 3: E 101, E 120, E 140, E 141, E 153, E 160b, E 160a, E 160c, E 160e, E 160f, E 162, E 163, E 171, E 172, E 174, E 175
31 Dec 2015 Preservatives and antioxidants: E 200-203; E 210-215, E 218-252, E 280-285; E 300-E 321, E 586 (priorities: E 310-312, E 320, E 321, E 220-228, E 304, E 200-203, E 284, E 285, E 239, E 242, E 249, E 250, E 251, E 252, E 280-283, E 306, E 307, E 308, E 309)
31 Dec 2016 Emulsifiers, stabilisers, gelling agents: E 322, E 400-E 419, E 422-E 495, E 1401-E 1451 (priorities: E 483, E 491-495, E 431, E 432-436, E 444, E 481, E 482, E 414; E 410, E 417, E 422, E 475)
31 Dec 2016 E 551, E 620-625, E 1105, E 1103
31 Dec 2018 All remaining food additives other than colours and sweeteners (priorities: E 552, E 553a, E 553b, E 558, E 999, E 338-343, E 450-452, E 900, E 912, E 914, E 902, E 904, E 626-629, E 630-633, E 634-635, E 507-511, E 513)
31 Dec 2020 All sweeteners and remaining colours

* Re-evaluation of E 132 (Indigo carmine) is awaiting the assessment of new data.

EFSA's activities

EFSA’s work on food additives is carried out by the Panel on Food Additives and Nutrient Sources Added to Food (ANS). The Panel’s safety evaluations involve a review of all available, relevant scientific studies and data on toxicity as well as human exposure, from which the Panel draws conclusions regarding the safety of the substance for human health.

New food additives

Authorisation of a new food additive or of proposed new uses of existing food additives requires submission of a formal request to the European Commission with an application dossier on the substance stating its intended uses and including scientific data concerning its safety. If the application is accepted, the Commission formally asks EFSA for its scientific opinion on the safety of the substance for its intended uses.

In line with Regulation EC 1331/2008, in July 2009 the ANS Panel adopted a statement specifying the type of data that industry should provide for the safety assessment of food additives. In June 2012, the ANS Panel adopted new guidance for the submission of food additive applications, reflecting advances in science and the latest risk assessment principles. This document replaces guidance originally established in 2001 by the European Commission’s former Scientific Committee on Food (SCF) and endorsed by EFSA’s Panels for use in their risk assessments.

An exposure assessment tool, the ‘Food additives intake model’ (FAIM) template, was specifically developed by EFSA, to support the calculation by applicants of estimates of exposure to the food additive and its by-products and to harmonise the submission of the related data.

Once a request for an opinion has been accepted by EFSA it is included in the Register of requested opinions where its status is can be monitored including date of reception and anticipated timing of finalisation and adoption.

Re-evaluation of food additives authorised before 20 January 2009

In its re-evaluations of previously authorised food additives, EFSA is required to review all the relevant scientific literature including, where necessary, the original scientific evaluation, and may also publish a call for data. Based on the timeline for re-evaluations set by the Commission in Annex II of Regulation EU 257/2010, the ANS Panel adopted a strategy for completing this work within the specified deadlines.

In its strategy, the Panel set the following criteria for scheduling the re-evaluation of the various types of additives:

  • The priorities set in the Regulation EU 257/2010 re-evaluation programme
  • The existence of new scientific evidence or technical information made available since the last evaluation which may affect the assessment of the safety of a food additive
  • The time lapsed since the last evaluation of a food additive by the SCF or by EFSA
  • Cases where an ADI could not be established or a temporary ADI was established by the SCF or the basis for the ADI established by the SCF was unclear.

In May 2014, the ANS Panel adopted a statement setting the criteria used in its risk assessments for certain food additives included in the re-evaluation programme.

Re-evaluation of food additives: tentative work programme 2014-2015 (0.1 Mb)

Main work in progress

EFSA’s work on food additives used as colours, and the sweetener aspartame are detailed separately:

Ongoing work in the area of food additives:

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Last updated: 4 December 2014